Exhibit 10.48

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT MARKED WITH [***]
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT, AS AMENDED.

SECOND AMENDMENT OF

THE LICENSE, DEVELOPMENT, SUPPLY AND DISTRIBUTION AGREEMENT

This SECOND AMENDMENT OF THE LICENSE, DEVELOPMENT, SUPPLY AND DISTRIBUTION
AGREEMENT (this “Second Amendment”) is made and effective as of January 29, 2013
(the “Second Amendment Effective Date”) by and among Allergan Sales, LLC, a
Delaware corporation with its principal place of business at 2525 Dupont Drive,
Irvine, California 92612 (“Allergan Sales”), Allergan USA, Inc., a Delaware
corporation with its principal place of business at 2525 Dupont Drive, Irvine,
California 92612 (“Allergan USA”), Allergan, Inc., a Delaware corporation with
its principal place of business at 2525 Dupont Drive, Irvine, California 92612
(“Allergan, Inc.” and, collectively with Allergan Sales and Allergan USA,
“Allergan”) and Spectrum Pharmaceuticals, Inc. (“Spectrum”), a Delaware
corporation with its principal place of business at 11500 S. Eastern Avenue,
Henderson, Nevada 89052. Allergan and Spectrum are collectively referred to
herein as the “Parties” and individually as a “Party”.

WHEREAS, Allergan Sales, Allergan USA, Allergan, Inc. and Spectrum are parties
to that certain License, Development, Supply and Distribution Agreement, dated
October 28, 2008 and amended June 13, 2011 (the “License Agreement”), pursuant
to which Spectrum granted Allergan the exclusive right to commercialize certain
products containing Apaziquone in certain territories, and the Parties otherwise
agreed to collaborate in the development and commercialization of such products;

WHEREAS, Allergan Sales, Allergan USA and Spectrum are also parties to that
certain Co-Promotion Agreement, dated October 28, 2008 (the “Co-Promotion
Agreement”), pursuant to which the Parties agreed to co-promote Licensed Product
(as defined in the License Agreement) in the use for the treatment of bladder
cancer, or pre-bladder cancer, conditions (the “Field of Use”);

WHEREAS, Spectrum now wishes to acquire back all the licensed rights to
development and commercial activities for such products under the License
Agreement and the Co-Promotion Agreement, and Allergan agrees to return to
Spectrum all such rights to develop and commercialize such products, in
consideration of which Spectrum has agreed to pay Allergan specified royalties
on the future sales of Royalty Product (as defined herein); and

WHEREAS, the Parties desire to amend the License Agreement, terminate the
Co-Promotion Agreement and set forth the terms and conditions under which
Allergan will return, and Spectrum will accept, the rights to such products, all
as set forth below.

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NOW THEREFORE, in consideration of the foregoing premises and the mutual
promises, covenants and conditions contained in this Second Amendment, the
Parties agree as follows:

1. Unless otherwise indicated, capitalized terms used but not defined herein
shall have the meanings set forth in the License Agreement.

2. In consideration of Spectrum’s acquisition of the licensed rights to
development and commercial activities for the Licensed Product back from
Allergan, the Parties hereby agree that, notwithstanding anything to the
contrary in the License Agreement, Allergan shall have no further liability for
any costs or expenses of any kind, including without limitation, any Development
Costs incurred after December 31, 2012 and from and after December 31, 2012,
Allergan shall have no obligations or liability under the License Agreement or
Co-Promotion Agreement including, without limitation, any obligations or
liability regarding development, regulatory or other responsibilities or
activities of any kind (collectively, the “Purpose”).

3. To effectuate the Purpose, as of the Second Amendment Effective Date, the
licenses granted to Allergan under Article 2 of the License Agreement are
terminated. Allergan confirms that it did not grant any sublicenses under such
licenses while they were in effect.

4. Product Royalty.

(a) Royalty. In consideration of the Purpose and Allergan’s economic
contribution as a party to the License Agreement and the Co-Promotion Agreement,
Spectrum shall pay to Allergan a royalty on the Royalty Net Sales (as defined
below) of Licensed Product in the Field of Use or for the treatment of upper
urinary tract carcinoma (collectively, “Royalty Product”) by Spectrum, its
Affiliates or sublicensees of Spectrum or its Affiliates within the Allergan
Territory, as set forth in the table below (the “Royalty”):

 

Net Sales of Royalty

Product In The Allergan

Territory Each Fiscal Year

   Royalty
Rate  

First [***] Dollars ($[***])

     [*** ]% 

Amounts Greater Than [***] Dollars ($[***])

     [*** ]% 

“Royalty Net Sales” means, with respect to a given period of time, the gross
amounts invoiced in such period, less the following deductions from such gross
amounts which are actually incurred, allowed, paid, accrued or specifically
allocated:

(1) credits or allowances actually granted for damaged products, returns or
rejections of product, price adjustments and billing errors;

 

[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

 

2

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(2) governmental and other rebates (or equivalents thereof) granted to managed
health care organizations, pharmacy benefit managers (or equivalents thereof),
federal, state/provincial, local and other governments, their agencies and
purchasers and reimbursers or to trade customers;

(3) normal and customary trade, cash and quantity discounts, allowances and
credits actually allowed or paid;

(4) distribution services agreement fees allowed or paid to Third Party
distributors;

(5) transportation costs, including insurance, for outbound freight related to
delivery of the product to the extent included in the gross amount invoiced;

(6) sales taxes, VAT taxes and other taxes directly linked to the sales of the
Royalty Product to the extent included in the gross amount invoiced; and

(7) any other items that reduce gross sales amounts as required by United States
Generally Accepted Accounting Principles applied on a consistent basis.

Sales between or among Spectrum or its Affiliates or sublicensees of Spectrum or
Spectrum’s Affiliates shall be excluded from the computation of Net Sales, but
the subsequent final sales to Third Parties by such Party, Affiliates or
sublicensees shall be included in the computation of Net Sales.

For clarity, and without limitation, a Royalty shall be paid on Royalty Products
regardless of whether or not closed system packaging is included or utilized.

(b) Calculations. Notwithstanding Subsection 4(a) above:

(i) no royalty payments shall be due for Royalty Product which is sold and
returned as defective, unusable, rejected by a purchaser; and

(ii) no royalty payments shall be due for Royalty Product which is used or
provided to others by Spectrum, its Affiliates or its or their sublicensees
solely for promotion (without consideration), research, conducting clinical
trials, demonstration, evaluation, testing or training purposes.

 

[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

 

3

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(c) No Patent Protection. If any Royalty Product is sold in a country in the
Allergan Territory in which (i) there is no Patent Protection (as defined
below), (ii) there is no Regulatory Exclusivity (as defined below), and (iii) a
Generic Product (as defined below) exists, then the royalty rates set forth in
Subsection 4(a) of this Second Amendment for such Royalty Product shall be
[***]. “Generic Product” means, with respect to a Royalty Product in the Field
of Use in a particular country in the Allergan Territory, another pharmaceutical
product that: (x) contains as an active ingredient Apaziquone; and (y) is
approved for use in such country (pursuant to 21 U.S.C. 355(b)(2), an ANDA, a
separate NDA, compendia listing, other drug approval application or otherwise,
including foreign equivalents of the foregoing, as applicable).“Patent
Protection” means, in the country of sale in the Allergan Territory, that at
least one of the claims of an issued and unexpired patent included within the
Licensed Intellectual Property, which would be infringed by the sale of such
Royalty Product in that country, is in effect and has not been revoked or held
unenforceable or invalid by a final decision of a court or other governmental
agency of competent jurisdiction having authority over said patent and that
final decision is not appealed or unappealable (all claims are considered valid
until so adjudicated and during prosecution of a patent application containing
such claims) and is sufficient to prevent a Generic Product from being sold in
such country. “Regulatory Exclusivity” means market exclusivity granted by a
Governmental Authority designed to prevent the entry of Generic Product(s) onto
the market in the Field of Use, including new chemical entity exclusivity, new
use or indication exclusivity, new formulation exclusivity, orphan drug
exclusivity, pediatric exclusivity and 180-day generic product exclusivity.

(d) Royalty Term. Spectrum’s royalty obligations shall commence on the first
commercial sale of a Royalty Product and expire, on a country-by-country basis,
on the later of: (i) the expiration or earlier invalidation of all of the
patents in the Licensed Intellectual Property claiming the composition of matter
of, the formulation of, or the method of making or using, such Royalty Product
in such country; (ii) [***] ([***]) years after the first commercial sale of
such Royalty Product in such country; or (iii) the expiration of all Regulatory
Exclusivity covering such Royalty Product in such country. “Royalty Term” means
the period of time from the Second Amendment Effective Date to that date upon
which Spectrum’s royalty obligation expires in all countries within the Allergan
Territory.

(e) Royalty Payment Schedule. Within five (5) business days after the end of
each Fiscal Quarter during which a Royalty Product is sold by Spectrum, its
Affiliates or its or their sublicensees, Spectrum shall provide to Allergan the
estimated royalty payment calculation. Within forty-five (45) days after the end
of each Fiscal Quarter during which a Royalty Product is sold by Allergan, its
Affiliates or its or their sublicensees, Spectrum shall deliver to Allergan a
detailed report, which shall include at least: (i) the net quantity sold, total
sales, total to net deductions, and Net Sales of Royalty Product sold in the
prior Fiscal Quarter; (ii) the calculation in U.S. dollars of royalty payments
due hereunder with respect to such sales; and (iii) the total due hereunder for
such Fiscal Quarter. Simultaneously with the delivery of each such report,
Spectrum shall pay to Allergan the total due hereunder for such Fiscal Quarter.

(f) Currency of Payments. All payments under this Second Amendment will be made
in U.S. dollars by electronic funds transfer to such bank accounts as each Party
may designate from time to time, or by check. When Royalty Product is sold for
monies other than U.S. dollars, the exchange rate shall be determined based on
the average daily exchange rate calculated by averaging the closing daily rate
between the country in which the Royalty Product was sold and the U.S., as
obtained from Bloomberg or equivalent successor (absent manifest error therein),
on a monthly basis during the Fiscal Quarter that Spectrum records the sale for
accounting purposes.

 

[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

 

4

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(g) Books; Records. During the Royalty Term and for three (3) years thereafter,
Spectrum shall keep and maintain at its regular places of business complete and
accurate books, records and accounts in accordance with the U.S. Generally
Accepted Accounting Principles, or other accounting standards mandated by the
U.S. Securities and Exchange Commission, in sufficient detail to reflect all
amounts required to be paid under this Second Amendment, as well as any other
books, records or accounts required to be maintained in connection with the
Royalty Product under any applicable Law. Prior to destroying any books, records
or accounts which are material to the Allergan’s rights and obligations under
this Second Amendment, Spectrum must seek prior written consent from Allergan,
which consent may not be unreasonably withheld.

(h) Audits. During the Royalty Term and for three (3) years thereafter, Allergan
(including a firm of certified public accountants engaged for such purpose)
shall have access to and the right to examine such relevant records and accounts
that Spectrum is required to maintain pursuant to Subsection 4(g) of this Second
Amendment at Spectrum’s premises for the sole purpose of verifying the payments
owed to Allergan hereunder; provided, however, that any such examination:
(i) shall be at Allergan’s expense; (ii) shall be during normal business hours
upon reasonable prior written notice which shall in no event be less than five
(5) business days; and (iii) shall not unreasonably interfere with Spectrum’s
operations and activities. Allergan may not re-audit Spectrum’s records for a
given period of time once audited unless a discrepancy has been discovered. All
information reviewed during any such examination shall be treated as
Confidential Information of Spectrum except as necessary in connection with the
enforcement or interpretation under this Second Amendment. Spectrum shall
promptly pay to Allergan any underpayment discovered in the course of such
audit, together with interest at the rate specified in Subsection 4(k) of this
Second Amendment accrued from the date due until paid. Notwithstanding
Subsection 4(h)(i) above, if the audit uncovers an underpayment that is more
than five percent (5%) of the amount payable for the period subject to such
audit, Spectrum shall reimburse Allergan for its out-of-pocket expense of such
audit.

(i) Withholding Taxes. Notwithstanding anything to the contrary herein, in the
event that withholding taxes apply with respect to any amounts due by Spectrum
hereunder, Spectrum shall be entitled to withhold from any payment due to
Allergan under this Second Amendment any taxes that Spectrum is required to pay
and such withholding shall decrease by an equivalent amount on the payment due
to Allergan. Spectrum shall provide Allergan with notification of any
anticipated withholding requirements with as much advance notice as practicable
and shall cooperate in good faith with Allergan to legally minimize such
withholding taxes. Spectrum will timely pay to the proper governmental authority
the amount of any taxes withheld and will provide Allergan with an official tax
certificate or other evidence of tax obligation, together with proof of payment
from the relevant governmental authority sufficient to enable Allergan to claim
such payment of taxes.

(j) Spectrum’s Obligations. Spectrum shall be solely responsible for, and shall
pay, any royalties or other payments due under the [***], the [***] or any other
license to the Licensed Intellectual Property.

 

[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.

 

5

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(k) Late Payment. If Allergan does not receive payment of any sum due to it on
or before the due date, simple interest shall thereafter accrue on the sum due
to Allergan from the due date until the date of payment at a rate equal to
LIBOR, as reported in the Wall Street Journal, plus one percent (1%) or the
maximum rate allowable by applicable law, whichever is less.

5. In consideration of the Purpose and the Royalty, Spectrum shall have the
right to continue to use the data and results generated under the License
Agreement before the Second Amendment Effective Date for its manufacture,
development and/or commercialization of products containing Apaziquone anywhere
in the world. Allergan hereby represents and warrants that to its knowledge, as
of the Second Amendment Effective Date, there is no Allergan Intellectual
Property Rights in either, any Allergan Solely Developed Know-How or any Joint
Intellectual Property that have been incorporated in the Licensed Product in the
Field of Use, or the making or using thereof.

6. Subject to regulatory approval to the extent applicable, Allergan shall
assign to Spectrum all regulatory filings relating to the Licensed Product in
the Field of Use in the Allergan Territory that are in the name of Allergan, its
Affiliates and its or their sublicensees, if any. The Parties shall cooperate in
good faith toward a goal of completing such assignment within thirty (30) days
after the Second Amendment Effective Date or as soon as reasonably practicable
thereafter.

7. Allergan hereby agrees to assign to Spectrum all right, title and interest in
and to the trademarks specified on Exhibit 1 hereto, including the accompanying
goodwill; provided, however, with respect to any abandoned application,
Allergan’s obligation to assign shall only apply to the extent such abandoned
application is reasonably assignable. The Parties shall cooperate in good faith
toward a goal of completing such assignment within thirty (30) days after the
Second Amendment Effective Date or as soon as reasonably practicable thereafter.
Allergan consents to Spectrum’s continued ownership of the “eoquin” domain names
registered in the name of Spectrum.

8. Allergan shall, to the extent assignable, assign to Spectrum the contracts
listed on Exhibit 2 hereto, which were entered into by Allergan in connection
with the development, manufacturing and/or commercialization of the Licensed
Product in the Field of Use in the Allergan Territory. The Parties shall
cooperate in good faith toward a goal of completing such assignment within
thirty (30) days after the Second Amendment Effective Date or as soon as
reasonably practicable thereafter.

9. Allergan hereby represents and warrants that as of the Second Amendment
Effective Date, it does not possess any inventory of Licensed Product.

10. Spectrum hereby agrees to defend, indemnify and hold harmless Allergan
Indemnitees from and against any Losses arising out of a Claim by a Third Party
(other than an Affiliate of Allergan) arising out of, resulting from or relating
to the manufacture, development or commercialization of pharmaceutical products
containing Apaziquone by Spectrum, its Affiliates or its or their sublicensees,
on or after the Second Amendment Effective Date. Spectrum’s obligations under
this Section 10 shall be subject to the indemnification procedures of
Section 12.3 of the License Agreement.

 

6

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11. To effectuate the Purpose, as of the Second Amendment Effective Date:

 

  (a) all rights and obligations of both Parties under the License Agreement are
hereby terminated, except for following portions of the License Agreement that
will survive the termination: Article 1 (including Schedule 1) (Definitions;
Interpretation); Article 9 (Confidential Information) (but as to Sections 9.1
thru 9.3 only for three (3) years from the Second Amendment Effective Date; for
clarity, Section 9.4 (Independent Development; Residuals) shall continue after
the three (3) year period); Article 12 (Indemnification; Limitations on
Liability; Insurance Requirements) (but only to the extent any Loss arises prior
to the Second Amendment Effective Date) and Section 12.3 (but only as applicable
to Spectrum under this Second Amendment); Article 14 (Miscellaneous) (other than
Sections 14.3, 14.6 and 14.12); Section 6.9 (Books; Records); Section 6.10
(Audits); Section 6.11 (Offset); Section 6.13 (Withholding Taxes); Section 6.15
(Late Payment) (for these Sections in Article 6, only as they relate to payments
accrued before the Second Amendment Effective Date); Section 8.1 (Ownership);
Section 8.2(a) and (8.2(b) (Prosecution) (as it relates to Joint Intellectual
Property only and for clarity these sections shall not create or preserve any
payment obligations of Allergan from and after December 31, 2012). For clarity,
the appointment of Allergan as Spectrum’s agent under Section 5.1(a)(ii) is
hereby terminated as of the Second Amendment Effective Date and Allergan shall
have no obligations or liability under the License Agreement or Co-Promotion
Agreement including, without limitation, any obligations or liability regarding
development, regulatory or other responsibilities or activities of any kind; and

 

  (b) the Co-Promotion Agreement is hereby terminated.

12. After the Second Amendment Effective Date, (i) Allergan shall promptly
deliver to Spectrum or destroy (at Allergan’s option) all Confidential
Information of Spectrum, subject to Allergan retaining a copy of such
Confidential Information solely as may be reasonably necessary for Allergan to
perform under this Second Amendment and for legal archival purposes and/or as
may be required by Law, and (ii) Spectrum shall promptly deliver to Allergan or
destroy (at Spectrum’s option) all Confidential Information of Allergan, subject
to Spectrum retaining a copy of such Confidential Information solely as may be
reasonably necessary for Spectrum to perform under this Second Amendment and for
legal archival purposes and/or as may be required by Law. For clarity,
Confidential Information of Allergan shall exclude the data and results
generated under the License Agreement and regulatory filings assigned by
Allergan to Spectrum pursuant to Section 6 of this Second Amendment, if any.

13. The Parties agree to the press release attached hereto as Exhibit 3
announcing the Second Amendment and the Purpose. The Parties further agree that
such press release shall be issued no later than close of business February 1,
2013. Further, from and after the Second Amendment Effective Date, each Party
shall not mention the other Party or its Affiliates in any press release or
other public statements concerning this Amendment, the Purpose, the License
Agreement or the Co-Promotion Agreement without first, in each instance:
(a) providing such statement to the other Party for review at least two full
(2) business days in advance of making such proposed statement, and
(b) obtaining the other’s Party’s express written consent to such statement,
which shall not be unreasonably withheld; provided, that the other Party’s
review and consent shall not be required in connection with a Party making a
public statement that conforms in all material respects to the language in
Exhibit 3 or that is determined, based on advice of legal counsel, to be
required by applicable Law.

 

7

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14. Each Party hereby acknowledges and agrees that, as of the Second Amendment
Effective Date, to the knowledge of such Party, the other Party has fulfilled
its obligations under the License Agreement and Co-Promotion Agreement and
neither Party is in breach of the License Agreement or Co-Promotion Agreement.

15. This Second Amendment amends the terms of the License Agreement as expressly
provided above, and the License Agreement, as so amended, along with the Second
Amendment, sets forth the complete, final and exclusive agreement and all the
covenants, promises, agreements, warranties, representations, conditions and
understandings between the Parties hereto with respect to the subject matter of
the License Agreement and supersedes, as of the Second Amendment Effective Date,
all prior and contemporaneous agreements and understandings between the Parties
with respect to the subject matter of the License Agreement. There are no
covenants, promises, agreements, warranties, representations, conditions or
understandings, either oral or written, between the Parties other than as set
forth in this Second Amendment and the License Agreement (as amended by this
Second Amendment).

16. The validity, performance, construction, and effect of this Second Amendment
shall be governed by and construed under the laws of the State of New York,
without giving effect to any choice of law principles that would require the
application of the laws of a different state.

17. This Second Amendment may be executed in one (1) or more counterparts, each
of which shall be deemed an original, but all of which shall constitute one and
the same instrument.

[ remainder of page intentionally left blank ]

 

8

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IN WITNESS WHEREOF, the Parties have caused this Second Amendment of the
License, Development, Supply and Distribution Agreement to be executed on the
Second Amendment Effective Date.

 

ALLERGAN SALES, LLC By:   /s/ Jeffrey L. Edwards Name:   Jeffrey L. Edwards
Title:   Vice President and   Chief Financial Officer ALLERGAN USA, INC. By:  
/s/ Jeffrey L. Edwards Name:   Jeffrey L. Edwards Title:   Vice President and  
Chief Financial Officer ALLERGAN, INC. By:   /s/ Jeffrey L. Edwards Name:  
Jeffrey L. Edwards Title:   Executive Vice President, Finance and Business
Development,   Chief Financial Officer SPECTRUM PHARMACEUTICALS, INC. By:   /s/
Brett L. Scott Name:   Brett L. Scott Title:   Senior Vice President   Acting
Chief Financial Officer

 

9

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Exhibit 1

Trademarks

EOQUIN either (a) as a stand-alone mark or (b) as the mark has been used in
combination with any other words, stylizations, logos, or designs so as to
create a unitary trademark

Applications

 

Country

   Mark      Application No.      Filing Date      Status  

European Union

     EOQUIN         005317086         9/15/06         Abandoned   

Registrations

 

Country

   Mark      Registration No.      Registration
Date      Status  

Canada

     EOQUIN         TMA838454         12/14/2012         Issued   

Japan

     EOQUIN         5041987         4/20/07         Issued   

United States

     EOQUIN         3,171,995         11/14/06         Issued   

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Exhibit 2

List of Contracts to be Assigned to Spectrum

None

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Exhibit 3

Press Release Announcing the Second Amendment and the Purpose

Spectrum Pharmaceuticals Acquires Rights for Apaziquone in the U.S., Europe and
Other Territories from Allergan; Expects to File New Drug Application

 

  •  

Based on communication with the FDA, Spectrum anticipates an Advisory Committee
meeting to review a potential NDA for apaziquone.

 

  •  

The Company expects to file an NDA, which Spectrum will seek to expedite as part
of a plan to achieve potential commercialization of apaziquone in key markets.

 

  •  

Apaziquone is in development to treat non-muscle invasive bladder cancer (NIMBC)
as a single instillation following transurethral resection of bladder tumor
(TURBT).

 

  •  

Approximately 70% of all patients with newly diagnosed bladder cancer have
NMIBC, and yet there are no FDA-approved agents for post resection chemotherapy.

HENDERSON, Nev. – January 31, 2013 — Spectrum Pharmaceuticals (NasdaqGS: SPPI),
a biotechnology company with fully integrated commercial and drug development
operations with a primary focus in hematology and oncology, today announced the
Company has reacquired development and commercialization rights for apaziquone
in the United States, Europe and other territories pursuant to an agreed-upon
restructuring of Spectrum’s collaboration with Allergan, Inc. In exchange,
Allergan will receive a royalty on future revenue. Apaziquone is an anticancer
agent being developed for the treatment of non-muscle invasive bladder cancer
(NIMBC) as a single instillation following transurethral resection of bladder
tumor (TURBT).

Spectrum also announced that a scheduled meeting with the U.S. Food & Drug
Administration (FDA) was held last month to discuss the results from the
Company’s Phase 3 clinical trials. Based on the discussions with the FDA,
Spectrum understands that the FDA can accept the NDA filing with the current
Phase III data and will likely convene an Advisory Committee meeting. Further,
based on discussions with the FDA, Spectrum has agreed to conduct one additional
Phase III study following consultation with the FDA on its design.

“Regaining apaziquone rights will enable Spectrum to take the steps we believe
are essential to advancing apaziquone toward commercialization in the U.S.,
Europe and other key territories,” stated Rajesh C. Shrotriya, M.D., Chairman,
President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc.
“Spectrum is committed to expediting our program for apaziquone, with the goal
of accelerating potential registration and integrating apaziquone into our plan
to expand our footprint in the U.S. and build our presence in the EU. Spectrum
is grateful to the FDA for its thoughtful feedback on the apaziquone clinical
program. We believe there continues to be a significant unmet need as no drugs
have been approved and marketed in the U.S. for more than 20 years for low-grade
NMIBC.”

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Apaziquone is an anticancer drug that requires activation by bio-reductive
enzymes that are over-expressed in bladder cancer cells, to render it a
cytotoxic alkylating agent. Spectrum conducted two multi-center, international
Phase 3 trials of a single dose of intravesical instillation of apaziquone into
the bladder in the immediate post-operative period after surgical resection of
low-grade, non-muscle invasive bladder tumors. In April 2012, Spectrum announced
that the Phase 3 trials did not meet their primary endpoint of a statistically
significant difference in the rate of tumor recurrence at 2 years between
treatment and placebo arms. However, analysis of the pooled data from both
studies showed a statistically significant treatment effect in favor of
apaziquone in the primary endpoint of the rate of tumor recurrence at 2 years
(p-value = 0.0174) and in a key secondary endpoint, time to recurrence (p-value
= 0.0076).

NMIBC is a form of bladder cancer localized in the surface layers of the bladder
that has not spread to the deeper muscle layer. Approximately 70% of all
patients newly diagnosed with bladder cancer have NMIBC. More than one million
patients in the U.S. and Europe are estimated to be affected by the disease,
which is treated predominantly by urologists. Professional urology associations
and NCCN Guidelines recommend instillation of a cytotoxic agent following
transurethral resection of bladder tumor (TURBT) for NMIBC. However, in the US,
there are no FDA-approved agents for this indication.

About Spectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals is a leading biotechnology company focused on
acquiring, developing, and commercializing drug products, with a primary focus
in oncology and hematology. Spectrum and its affiliates market three oncology
drugs – FUSILEV® (levoleucovorin) for Injection in the U.S.; FOLOTYN®
(pralatrexate injection), also marketed in the U.S.; and ZEVALIN® (ibritumomab
tiuxetan) Injection for intravenous use, for which the Company has worldwide
marketing rights. Spectrum’s strong track record in in-licensing and acquiring
differentiated drugs, and expertise in clinical development have generated a
robust, diversified, and growing pipeline of product candidates in
advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is
available at www.sppirx.com.

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Forward-looking statement — This press release may contain forward-looking
statements regarding future events and the future performance of Spectrum
Pharmaceuticals that involve risks and uncertainties that could cause actual
results to differ materially. These statements are based on management’s current
beliefs and expectations. These statements include, but are not limited to,
statements that relate to our business and its future, including certain company
milestones, Spectrum’s ability to identify, acquire, develop and commercialize a
broad and diverse pipeline of late-stage clinical and commercial products,
leveraging the expertise of partners and employees around the world to assist us
in the execution of our strategy, and any statements that relate to the intent,
belief, plans or expectations of Spectrum or its management, or that are not a
statement of historical fact. Risks that could cause actual results to differ
include the possibility that our existing and new drug candidates may not prove
safe or effective, the possibility that our existing and new applications to the
FDA and other regulatory agencies may not receive approval in a timely manner or
at all, the possibility that our existing and new drug candidates, if approved,
may not be more effective, safer or more cost efficient than competing drugs,
the possibility that our efforts to acquire or in-license and develop additional
drug candidates may fail, our lack of sustained revenue history, our limited
marketing experience, our dependence on third parties for clinical trials,
manufacturing, distribution and quality control and other risks that are
described in further detail in the Company’s reports filed with the Securities
and Exchange Commission. We do not plan to update any such forward-looking
statements and expressly disclaim any duty to update the information contained
in this press release except as required by law.

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