As filed with the Securities and Exchange Commission on April 9, 1999
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
Amendment No. 1 to
THE SECURITIES ACT OF 1933
MAGAININ PHARMACEUTICALS INC.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer Identification No.)
incorporation or organization) Classification No.)
5110 Campus Drive
Plymouth Meeting, PA19462
(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, PA19462
(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
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. [_]
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),
SUBJECT TO COMPLETION, DATED JUNE 11, 1999PROSPECTUS
Magainin Pharmaceuticals Inc.
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. 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. See "SellingStockholder."
Genentech has not advised us of any specific plans for the
distribution of the shares covered by this prospectus. However, we
anticipate that the shares will be sold from time to time primarily in
transactions, including 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 June 7, 1999 the last reported closing price of our
common stock was $1.9063 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 11, 1999
TABLE OF CONTENTS
About this Prospectus................................................. 3
Our Company........................................................... 4
Risk Factors.......................................................... 6
Forward-Looking Statements............................................ 15
Where You Can Find More Information................................... 16
Use of Proceeds....................................................... 17
Selling Stockholder................................................... 17
Plan of Distribution.................................................. 17
Legal Opinion......................................................... 19
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.
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
. 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
. 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
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
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
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. (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, PlymouthMeeting, PA19462, and our telephone number is (610) 941-4020.
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
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
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.
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
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
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
. 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.
IF WE DO NOT DEVELOP AND MAINTAIN RELATIONSHIPS WITH CONTRACT MANUFACTURERS, WE MAY NOT SUCCESSFULLY COMMERCIALIZE OUR PRODUCTS. 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
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.
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.
Alternate 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-effective manufacturing process and,
even if we develop a more cost-effective process, the FDA may not approve such a
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.
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,
. 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 competing treatment
. 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 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:
. warning letters;
. withdrawal of regulatory approval;
. product recalls;
. operating restrictions;
. injunctions; and
. criminal prosecution.
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:
. grant marketing approval;
. require additional testing or information; or
. deny the application.
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
. the drug product can be consistently manufactured at the same quality
. the drug product is stable over time; and
. the level of chemical impurities in the drug product are under a designated
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 manufacturers; 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.
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
. require additional submissions if there are any modifications to the drug
product including, for example, any changes in manufacturing 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.
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.
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 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
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
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
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.
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 we have incurred. Our
ability to recoup these expenditures and profit could be diminished.
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
. 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
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 against allegations 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 us to cease using such technology.
The cost of litigation can be substantial, regardless of the outcome.
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
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.
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:
. our proposed products cause some undesirable side effects or injury during
. our commercialized products cause undesirable side effects or injury; or
. 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:
. product testing results,
. technological innovations,
. new commercial products,
. government regulations,
. proprietary rights,
. regulatory actions, and
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:
. 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
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
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 3,558,000 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
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.
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
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, IL60661 and 7 World Trade Center, Suite 1300, New York, NY10048. 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,
SEC file 000-19651;
. Our Current Report on Form 8-K filed with the SEC on January 7, 1999,
SEC file 000-19651;
. Our Current Report on Form 8-K filed with the SEC on March 15, 1999,
SEC file 000-19651; 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, SEC files 33-43579 and 000-19651
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, PlymouthMeeting, PA19462, (610) 941-5228.
USE OF PROCEEDS
We will not receive any proceeds from the sale of the shares by Genentech.
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:
. 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;
. purchases by a broker-dealer as principal and resale by such broker-dealer
for its account pursuant to this prospectus;
. ordinary brokerage transactions and transactions in which the broker
. privately negotiated transactions; and
. 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
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.
Morgan, Lewis & Bockius LLP, Philadelphia, Pennsylvania, will pass on the
validity of the shares.
The financial statements of Magainin Pharmaceuticals Inc. as of December31, 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.
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............. $18,000.00
All of the amounts shown are estimates except for the fees payable to the
Securities and Exchange Commission and the National Association of Securities
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.
Item 16. List of Exhibits
The exhibits filed as part of this registration statement are as follows:
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
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
(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
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.
** Previously filed.
Dates Referenced Herein and Documents Incorporated by Reference