Quarter highlighted by
* completion of NDA submission for satraplatin, now under priority review
at the FDA
* presentation of important data from satraplatin SPARC Phase 3 trial at
major medical conferences
MARTINSRIED/MUNICH, Germany and PRINCETON, N.J., May 15 /PRNewswire-
FirstCall/ -- GPC Biotech AG (Frankfurt Stock Exchange: GPC; TecDAX 30;
Nasdaq: GPCB) today reported financial results for the first quarter ended
March 31, 2007.
First quarter 2007 compared to first quarter 2006
Revenues decreased 30% to euro 3.8 million for the first quarter ended
March 31, 2007, compared to euro 5.4 million for the first quarter 2006.
The decrease in revenues is mainly due to lower development funding
received under the co-development and license agreement with Pharmion for
satraplatin for Europe and certain other territories, which reflects the
decrease in research and development (R&D) spending for the first quarter
of 2007. R&D expenses decreased 10% to euro 13.0 million for the first
three months of 2007 compared to euro 14.5 million for the same period in
2006. This decrease was mainly due to the maturation of the satraplatin
SPARC Phase 3 registrational study. In the first quarter of 2007, general
and administrative (G&A) expenses increased 150% to euro 11.0 million
compared to euro 4.4 million for the first quarter of 2006. This increase
is mainly due to expanded activities in marketing and sales and increased
legal expenses. Net loss for the first quarter of 2007 increased 49% to
euro (19.2) million compared to euro (12.9) million for the first quarter
of 2006. Basic and diluted loss per share was euro (0.54) for the first
quarter of 2007 compared to euro (0.41) for the same quarter in 2006.
As of March 31, 2007, cash, cash equivalents, marketable securities and
short-term investments totaled euro 112.8 million (December 31, 2006: euro
97.1 million), including euro 1.5 million in restricted cash. Net cash burn
for the first quarter of 2007 was euro 19.4 million. Net cash burn is
derived by adding net cash used in operating activities and purchases of
property, equipment and licenses. The figures used to calculate net cash
burn are contained in the Company's unaudited consolidated statements of
cash flows for the first quarter ended March 31, 2007.
Quarter over quarter results: first quarter 2007 compared to fourth
quarter 2006
Revenues for the first quarter of 2007 decreased 25% to euro 3.8
million compared to euro 5.1 million for the previous quarter. R&D expenses
decreased 17% to euro 13.0 million for the first quarter of 2007 compared
to euro 15.6 million for the fourth quarter of 2006. G&A expenses for the
first quarter of 2007 increased 45% to euro 11.0 million compared to euro
7.6 million for the previous quarter. The Company's net loss was euro
(19.2) million in the first quarter of 2007 compared to euro (17.2) million
for the previous quarter. Basic and diluted loss per share was euro (0.54)
for the first quarter of 2007 compared to euro (0.51) for the previous
quarter.
"For the fiscal year 2007, we confirm our guidance of stable revenues
compared to the euro 22.7 million we generated in 2006. We also reiterate
our guidance for 2007 of a moderate increase in R&D expenses and a
significant increase in G&A expenses due to the buildup of our commercial
organization," said Mirko Scherer, Ph.D., Senior Vice President and Chief
Financial Officer. "With cash, cash equivalents and available for sale
securities of euro 112.8 million as of March 31, we are in a solid
financial position to aggressively move forward with our plans for a
possible launch of satraplatin later this year."
Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer, said: "We
have already had several key achievements in the first few months of 2007,
including completion of the NDA submission for satraplatin and its
acceptance for filing by the FDA. We are very pleased that FDA has granted
the NDA submission priority review status and look forward to an action by
the agency in August this year."
Dr. Seizinger continued: "We are very busy preparing for the possible
U.S. launch of satraplatin later this year. With the acceptance of the NDA
filing and the assignment of priority review by the FDA, and with the
senior management of our U.S. marketing and sales organization in place, we
have begun to hire the field sales force. In addition, we continue to move
forward satraplatin clinical trials in other oncology indications, as well
as our other development and discovery programs."
Key Achievements: Year-to-Date 2007
* Private placement with institutional investors raising net proceeds of
euro 32.6 million
* Rolling submission of an NDA for satraplatin completed and accepted for
filing by the U.S. FDA
* NDA for satraplatin granted priority review status, setting target date
for FDA action in August 2007
* Key progression-free survival (PFS) results as well as positive data on
pain and PSA response rates from the satraplatin SPARC Phase 3
registrational trial in second-line chemotherapy for hormone-refractory
prostate cancer presented at major international oncology and urology
meetings
* Satraplatin Expanded Rapid Access protocol (SPERA) launched in the U.S.
Conference call scheduled
As previously announced, the Company has scheduled a conference call to
which participants may listen via live webcast, accessible through the GPC
Biotech Web site at http://www.gpc-biotech.com or via telephone. A replay will be
available via the Web site following the live event. The call, which will
be conducted in English, will be held on May 15 at 14:00 CEST/8:00 AM ET.
The dial-in numbers for the call are as follows:
Participants from Europe: 0049 (0)69 9897 2631 or 0044 (0)20 7138 0813
Participants from the U.S.: 1-718-354-1359
Please dial in 10 minutes before the beginning of the meeting.
About GPC Biotech
GPC Biotech AG is a publicly traded biopharmaceutical company focused
on discovering, developing and commercializing new anticancer drugs. GPC
Biotech's lead product candidate satraplatin is currently under review by
the U.S. FDA for hormone-refractory prostate cancer patients whose prior
chemotherapy has failed. Satraplatin was in-licensed from Spectrum
Pharmaceuticals, Inc. GPC Biotech is also developing a monoclonal antibody
with a novel mechanism-of-action against a variety of lymphoid tumors,
currently in Phase 1 clinical development, and has ongoing drug development
and discovery programs that leverage its expertise in kinase inhibitors.
GPC Biotech AG is headquartered in Martinsried/Munich (Germany), and has a
wholly owned U.S. subsidiary headquartered in Princeton, New Jersey. For
additional information, please visit GPC Biotech's Web site at
http://www.gpc-biotech.com.
This press release contains forward-looking statements, which express
the current beliefs and expectations of the management of GPC Biotech AG.
Such statements are based on current expectations and are subject to risks
and uncertainties, many of which are beyond our control, that could cause
future results, performance or achievements to differ significantly from
the results, performance or achievements expressed or implied by such
forward-looking statements. Actual results could differ materially
depending on a number of factors, and we caution investors not to place
undue reliance on the forward- looking statements contained in this press
release. In particular, additional information relating to the safety,
efficacy or tolerability of satraplatin may be discovered upon further
analysis of data from the SPARC trial or analysis of additional data from
other ongoing clinical trials for satraplatin. Furthermore, even if these
results are confirmed upon full analysis of the trial, we cannot guarantee
that satraplatin will be approved for marketing in a timely manner, if at
all, by regulatory authorities nor that, if marketed, satraplatin will be a
successful commercial product. We direct you to GPC Biotech's Annual Report
on Form 20-F for the fiscal year ended December 31, 2005 and other reports
filed with the U.S. Securities and Exchange Commission for additional
details on the important factors that may affect the future results,
performance and achievements of GPC Biotech. Forward-looking statements
speak only as of the date on which they are made and GPC Biotech does not
undertake any obligation to update these forward- looking statements, even
if new information becomes available in the future.
The scientific information discussed in this press release related to
satraplatin is investigative. Satraplatin has not yet been approved by the
FDA in the U.S., the EMEA in Europe or any other regulatory authority and
no conclusions can or should be drawn regarding its safety or
effectiveness. Only the relevant regulatory authorities can determine
whether satraplatin is safe and effective for the use(s) being
investigated.
GPC Biotech AG
Martin Braendle
Director, Investor Relations & Corporate Communications
Phone: +49 (0)89 8565-2693
ir@gpc-biotech.com
In the U.S.: Laurie Doyle
Director, Investor Relations & Corporate Communications
Phone: +1 609 524 5884
usinvestors@gpc-biotech.com
Additional Media Contacts:
In Europe:
Maitland
Brian Hudspith
Phone: +44 (0)20 7379 5151
bhudspith@maitland.co.uk
In the U.S.:
Russo Partners, LLC
David Schull
Phone: +1 212 845-4271
david.schull@russopartnersllc.com
- Financials follow -
Condensed Consolidated Statements of Operations (U.S. GAAP)
Three months ended March 31,
in thousand euro, except share and 2007 2006
per share data (unaudited) (unaudited)
Collaborative revenues (a) 3,762 5,398
Grant revenues 77 -
Total revenues 3,839 5,398
Research and development expenses 13,040 14,519
General and administrative expenses 11,023 4,377
Amortization of intangible assets 91 72
Total operating expenses 24,154 18,968
Operating loss (20,315) (13,570)
Other income (expense), net 157 (674)
Interest income 1,028 951
Interest expense (27) (22)
Net loss before cumulative effect of
change in accounting principle (19,157) (13,315)
Cumulative effect of change in accounting principle - 433
Net loss (19,157) (12,882)
Loss per share before change in accounting principle (0.54) (0.43)
Cumulative effect of change in accounting principle - 0.02
Basic and diluted loss per share (0.54) (0.41)
Shares used in computing basic and
diluted loss per share 35,441,336 31,317,316
(a) Revenues from related party
Collaborative revenues - 1,474
See accompanying notes to unaudited condensed consolidated financial
statements.
Condensed Consolidated Balance Sheets (U.S. GAAP)
in thousand euro, except share data and per share data
March 31, December 31,
Assets 2007 2006
(unaudited)
Current assets
Cash and cash equivalents 64,903 38,336
Marketable securities and short-term investments 46,362 57,186
Accounts receivable 2,330 11
Accounts receivable, related party - 395
Prepaid expenses 1,342 1,299
Other current assets 3,012 2,970
Total current assets 117,949 100,197
Property and equipment, net 4,472 4,259
Intangible assets, net 311 405
Other assets, non-current 1,110 1,127
Restricted cash 1,535 1,531
Total assets 125,377 107,519
Liabilities and shareholders' equity
Current liabilities
Accounts payable 2,155 2,262
Accrued expenses and other current liabilities 15,485 14,346
Current portion of deferred revenue 7,097 7,240
Current portion of deferred revenue, related party - 896
Total current liabilities 24,737 24,744
Deferred revenue, net of current portion 8,999 9,103
Convertible bonds 3,178 3,108
Other liabilities, non-current 3,163 3,389
Shareholders' equity
Ordinary shares, euro 1 non-par,
notional value:
Shares authorized: 62,695,630 at March 31, 2007
and December 31, 2006
Shares issued and outstanding: 35,948,448 at
March 31, 2007 and 33,895,444
at December 31, 2006 35,948 33,895
Additional paid-in capital 363,427 328,171
Subscribed shares 664 334
Accumulated other comprehensive loss (2,112) (1,755)
Accumulated deficit (312,627) (293,470)
Total shareholders' equity 85,300 67,175
Total liabilities and shareholders' equity 125,377 107,519
See accompanying notes to unaudited condensed consolidated financial
statements.
Condensed Consolidated Statements of Cash Flows (U.S. GAAP)
Three months ended March 31,
in thousand euro 2007 2006
(unaudited) (unaudited)
Cash flows from operating activities
Net loss (19,157) (12,882)
Adjustments to reconcile net loss to net cash
(used in) provided by operating activities:
Depreciation 423 434
Amortization 90 71
Compensation cost for stock option plans
and convertible bonds 2,566 1,560
Cumulative effect of change in
accounting principle - (433)
Change in accrued interest income on marketable
securities and short-term investments (157) (82)
Bond premium amortization 52 199
Gain on disposal of property and equipment (43) (28)
Changes in operating assets and liabilities:
Accounts receivable (2,320) 31,325
Accounts receivable, related party 395 1,436
Other assets, current and non-current (86) (1,425)
Accounts payable (92) (1,774)
Deferred revenue (247) (3,414)
Deferred revenue, related party (896) (1,203)
Other liabilities and accrued expenses,
current and non-current 772 (974)
Net cash (used in) provided by
operating activities (18,700) 12,810
Cash flows from investing activities
Purchases of property, equipment and licenses (657) (327)
Proceeds from the sale of property and equipment 45 -
Proceeds from the sale or maturity of marketable
securities and short-term investments 11,000 -
Net cash provided by (used in)
investing activities 10,388 (327)
Cash flows from financing activities
Proceeds from issuance of shares, net of
payments for cost of transaction 32,632 36,080
Proceeds from issuance of convertible bonds 262 140
Payments for cancellation of convertible bonds (4) -
Proceeds from exercise of stock options
and convertible bonds 2,143 426
Cash received for subscribed shares 330 -
Net cash provided by financing activities 35,363 36,646
Effect of exchange rate changes on cash (467) (209)
Changes in restricted cash (17) (14)
Net increase/(decrease) in cash
and cash equivalents 26,567 48,906
Cash and cash equivalents at the beginning
of the period 38,336 30,559
Cash and cash equivalents at the end
of the period 64,903 79,465
See accompanying notes to unaudited condensed consolidated financial
statements
Consolidated Statements of Changes in Shareholders' Equity (U.S. GAAP)
(in thousand euro, except share data)
Ordinary shares
Additional
Paid-in Subscribed
Shares Amount Capital Shares
Balance at December 31, 2005 30,151,757 30,152 284,931 -
Components of
comprehensive loss:
Net loss
Change in unrealized gain on
available-for-sale securities
Accumulated translation
adjustments
Total comprehensive loss
Issuance of shares 2,860,000 2,860 33,220
Exercise of stock options and
convertible bonds 77,476 77 368
Cumulative effect of change
in accounting principle (433)
Compensation cost for stock options
and convertible bonds 1,560
Balance at March 31,
2006 (unaudited) 33,089,233 33,089 319,646 -
Balance at December 31, 2006 33,895,444 33,895 328,171 334
Components of comprehensive
loss:
Net loss
Change in unrealized gain on
available-for-sale securities
Accumulated translation
adjustments
Total comprehensive loss
Issuance of shares 1,564,587 1,565 31,068
Exercise of stock options and
convertible bonds 488,417 488 1,842 330
Compensation cost for stock
options and convertible bonds 2,346
Balance at March 31,
2007 (unaudited) 35,948,448 35,948 363,427 664
Accumulated
Other Total
Comprehensive Accumulated Shareholders'
Loss Deficit Equity
Balance at December 31, 2005 (2,093) (229,457) 83,533
Components of comprehensive
loss:
Net loss (12,882) (12,882)
Change in unrealized gain on
available-for-sale
securities 130 130
Accumulated translation
adjustments (123) (123)
Total comprehensive loss (12,875)
Issuance of shares 36,080
Exercise of stock options and
convertible bonds 445
Cumulative effect of change
in accounting principle (433)
Compensation cost for stock
options and convertible bonds 1,560
Balance at March 31,
2006 (unaudited) (2,086) (242,339) 108,310
Balance at December 31, 2006 (1,755) (293,470) 67,175
Components of comprehensive
loss:
Net loss (19,157) (19,157)
Change in unrealized gain on
available-for-sale
securities 72 72
Accumulated translation
adjustments (429) (429)
Total comprehensive loss (19,514)
Issuance of shares 32,633
Exercise of stock options and
convertible bonds 2,660
Compensation cost for stock
options and convertible bonds 2,346
Balance at March 31,
2007 (unaudited) (2,112) (312,627) 85,300
See accompanying notes to unaudited condensed consolidated financial
statements
GPC Biotech AG
Notes to the Unaudited Condensed Consolidated Financial Statements
1. Basis of Presentation
The accompanying unaudited condensed consolidated financial statements
of GPC Biotech AG (the "Company") have been prepared in accordance with
accounting principles generally accepted in the United States ("U.S.
GAAP"), applicable to interim financial reporting, specifically Accounting
Principles Board Opinion No. 28 "Interim Financial Reporting". These
unaudited condensed consolidated financial statements do not include all
information and disclosures required for a complete set of financial
statements. However in the opinion of management, all adjustments
(consisting of normal recurring adjustments) considered necessary for a
fair presentation have been included. Operating results for the three-month
period ended March 31, 2007 are not necessarily indicative of results to be
expected for the full year ending December 31, 2007. The balance sheet at
December 31, 2006 has been derived from the audited consolidated financial
statements at that date but does not include all of the information
required by U.S. GAAP for complete financial statements. For further
information, refer to the consolidated financial statements and footnotes
thereto for the year ended December 31, 2006.
2. New Accounting Pronouncements
As of January 1, 2007, GPC Biotech adopted FASB Interpretation No. 48,
"Accounting for Uncertainty in Income Taxes, an interpretation of FASB
Statement No. 109" (FIN 48). The Company has certain deferred tax assets as
a result of several years of losses from operations. In accordance with FIN
48, management determined that it is more likely than not that sufficient
future taxable income will not be available to realize those deferred tax
assets. Therefore, management recognized a full valuation allowance for
those deferred tax assets.
The Company's policy is to accrue interest and penalties on the tax
obligations and classify them as current or noncurrent depending on when
the amount is anticipated to be paid. Currently, the Company does not take
any other tax positions nor has any interest or penalties.
3. Related Party Disclosures
ALTANA Pharma AG ("ALTANA Pharma") is no longer a related party with
the Company, because the board membership of Dr. Bernd Seizinger at ALTANA
Pharma ended December 31, 2006. Therefore, transactions consummated with
ALTANA Pharma from and after January 1, 2007 are no longer classified as
transactions with a related party.
4. Commitments and Contingencies
Contingent Commitments and Contingent Losses
From time to time, the Company may be party to certain legal
proceedings and claims which arise during the ordinary course of business.
The Company also has other contingencies relating to potential milestone
payments. Legal proceedings and contingent commitments are subject to
various uncertainties and the outcomes are difficult to predict. GPC
Biotech may incur significant expense in defending these or future legal
proceedings and in fulfilling these contingencies, however, in the opinion
of management, the ultimate outcome of these matters will not have material
adverse effects on the Company's financial position, results of operations
or cash flows. In accordance with SFAS No. 5, Accounting for Contingencies,
the Company makes a provision for a liability when it is both probable that
a liability has been incurred at the date of the financial statements and
when the amount of the loss is reasonably estimable. With respect to a
number of the items listed below, management has determined that a loss is
not probable or the amount of the loss is not reasonably estimable, or
both.
Arbitration Proceedings
On December 12, 2006, the Company was notified by Spectrum
Pharmaceuticals Inc. ("Spectrum"), that Spectrum had initiated an
arbitration proceeding with the American Arbitration Association ("AAA") in
the United States to resolve a dispute between the companies under the
co-development and license agreement for satraplatin. In the course of the
arbitration proceedings, Spectrum has made several claims of breach of
contract, including (1) an assertion that it is entitled to a payment from
GPC Biotech of approximately euro 9.0 million relating to payments received
by GPC Biotech under the co-development and license agreement between GPC
Biotech and Pharmion GmbH entered on December 19, 2005, (2) a claim that
GPC Biotech has not used commercially reasonable efforts to obtain
regulatory approval and to promote the distribution of satraplatin in
Japan, and (3) a claim that GPC Biotech has not negotiated with Spectrum in
good faith regarding the co-promotion of satraplatin in the United States.
Spectrum is also seeking a declaration that GPC Biotech's alleged breaches
of contract provide a basis for termination of the co-development and
license agreement. The Company believes that Spectrum's claims have no
merit and is therefore contesting such claims vigorously. Management
assessed the prospect of an unfavorable outcome of this arbitration as
highly unlikely. A three member arbitration panel has been selected and the
matter is currently scheduled to be heard by the panel in July 2007. Fees
which the Company pays to its external legal advisors and for other
services associated with this arbitration process are expensed in the
period when such legal and other services are rendered.
Marketing Approval of Satraplatin in the U.S. and Europe
Upon receiving marketing approval for satraplatin in the U.S. and/or
Europe, the Company is required to make the following payments:
* Under the Company's agreement with a third party, GPC Biotech is
obligated to make milestone payments for each of these approvals in a
total amount of approximately euro 6.7 million.
* The Company has a cash bonus plan to retain the Company's employees in
which the total payout may lead to an increase in personnel expenses of
up to euro 1.9 million.
* The Company issued stock appreciation rights (SARs) to senior
management, the members of the Supervisory Board, and certain employees.
These SARs would entitle the holder to cash payments if the performance
condition has been met.
Development and Supply Agreement
GPC Biotech is the owner and licensee of certain technology and patent
rights regarding the monoclonal antibody known as 1D09C3. In March 2007,
GPC Biotech entered into a development and supply agreement with a
biologics supplier under which the biologics supplier agreed to: (1)
develop a high- productivity cell line and develop and scale-up a robust
manufacturing process and (2) produce quantities of 1D09C3 bulk drug
substance for clinical development and commercial supply. Pursuant to the
agreement, GPC Biotech is required to make certain payments over a period
of 7 (seven) years. These payments will be charged to research and
development expenses as services are rendered.
Contingent Gains
The Company is entitled to receive a net milestone payment of
approximately euro 5.1 million upon the acceptance for filing of the first
Marketing Authorization Application (MAA) with the European Medicines
Agency (EMEA) and a net milestone payment of approximately euro 12.4
million upon the approval of the first MAA with EMEA. These contingent
gains will be recognized as revenue when the milestones are achieved.
5. Loss per Share
Basic loss per common share is computed using the weighted average
number of common shares outstanding during the period. Diluted net loss per
common share is computed using the weighted average number of common and
dilutive common equivalent shares from stock options and convertible debt
using the treasury stock method. For all periods presented, diluted net
loss per share is the same as basic net loss per share, as the inclusion of
weighted average shares of common stock issuable upon the exercise of stock
options and convertible debt would be antidilutive.
6. Comprehensive Loss
Comprehensive loss was euro 19.5 million and euro 12.9 million for the
three months ended March 31, 2007 and 2006, respectively. Comprehensive
loss is composed of net loss, unrealized gains and losses on marketable
securities and short-term investments and cumulative foreign currency
translation adjustments. Accumulated other comprehensive loss at March 31,
2007 and 2006 reflected euro 0.5 million of unrealized gains and euro 0.1
million of unrealized losses on marketable securities and short-term
investments and euro 2.6 million and euro 2.0 million of cumulative foreign
currency translation loss adjustments, respectively.
7. Shareholders' Equity
On January 24, 2007, the Company issued 1,564,587 new ordinary shares
at euro 21.50 per share for a total net amount of euro 32.6 million through
a private placement. GPC Biotech received the proceeds from the placement
after registration of the corresponding capital increase in the German
commercial register in February 2007.
At March 31, 2007, members of the management board and employees of the
Company had subscribed to 120,990 ordinary shares with a total value of
euro 663,700, which has been included in shareholders' equity. The
subscribed shares represent amounts paid for exercises of stock options for
which ordinary shares have not been issued at March 31, 2007. The ordinary
shares are expected to be registered and issued by June 30, 2007.
During the three months ended March 31, 2007, members of the management
board and employees of the Company exercised some of their fully vested
options and convertible bonds, receiving 488,417 new ordinary shares of the
Company.
8. Additional Disclosures
General and Administrative Expenses
General and administrative (G&A) expenses for the three months ended
March 31, 2007 increased 150% to euro 11.0 million compared to euro 4.4
million for the same period in 2006. The increase in G&A expenses is
primarily due to the formation of a sales and marketing organization in
anticipation of the Satraplatin product launch in the U.S., other
pre-launch as well as legal expenses.
Share-Based Compensation
Share-based compensation cost was euro 2,566,000 and euro 1,560,000 for
the three months ended March 31, 2007 and 2006, respectively.
9. Disclosures Required by the Frankfurt Stock Exchange
Number of Employees
As of March 31, 2007 and 2006, the number of employees totaled 261 and
224, respectively.
Shareholdings of Management
As of March 31, 2007 the members of the Management Board and
Supervisory Board held shares, stock options, convertible bonds and stock
appreciation rights in the amounts set forth in the table below:
Number Number Number
Number of of of Stock
of Stock Convertible Appreciation
Shares Options Bonds Rights
Management Board
Bernd R. Seizinger, M.D., Ph.D. 61,500 789,000 968,500 -
Elmar Maier, Ph.D. 170,000 95,000 329,000 -
Sebastian Meier-Ewert, Ph.D. 194,405 201,500 362,625 -
Mirko Scherer, Ph.D. 4,000 240,000 382,250 -
Supervisory Board
Jurgen Drews, M.D. (Chairman) 26,900 10,000 12,500 60,000
Michael Lytton (Vice Chairman) 7,500 10,000 31,500 45,000
Metin Colpan, Ph.D. 19,400 10,000 10,000 33,750
Prabhavathi Fernandes, Ph.D. - - 10,000 35,000
James Frates 1,000 - - 45,000
Peter Preuss 87,500 - 22,500 37,500
10. Subsequent Events
Acceptance of NDA Filing
On April 16, 2007, the U.S. Federal Drug Administration (FDA) accepted
the Company's filing of the New Drug Application (NDA) for satraplatin for
patients with hormone-refactory prostate cancer (HRPC) whose prior
chemotherapy has failed. In addition, the Company was also notified that
the FDA had granted the NDA priority review status. Priority review
designation is intended for those products that address significant unmet
medical needs and sets the target date for FDA action at six months from
the date of submission. The Company completed the rolling submission of the
NDA for satraplatin on February 15, 2007 and an action on the application
from the FDA is expected in August 2007. The application will be reviewed
under the provision of 21 CFR 314 Subpart H, for accelerated approval.
In connection with the above acceptance, the Company is required to pay
approximately euro 3.0 million to a third party. This amount was charged to
research and development expense in 2006 when the occurrence of this event
was deemed as probable.
Drug Discovery Reorganization
On May 3, 2007, the Company announced the consolidation of its drug
discovery efforts to one location, resulting in the closing of the facility
in Waltham, Massachusetts along with a total workforce reduction of
approximately 16%. The Company currently estimates the costs of closing the
facility to total approximately euro 1.0 million, which are primarily
related to employee severance and termination benefits and other closing
costs. The Company expects such costs to continue through December 2007.
These charges will be classified separately in the statement of operations,
in accordance with SFAS No. 146, "Accounting for Costs Associated with Exit
or Disposal Activities."
SOURCE GPC Biotech AG
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Related links:
http://www.gpc-biotech.com
CONTACT:
Martin Braendle, Director, Investor Relations
& Corporate Communications, +49 (0)89 8565-2693, or
ir@gpc-biotech.com, or Laurie Doyle, Director, Investor Relations
& Corporate Communications, +1 609 524 5884, or
usinvestors@gpc-biotech.com, both of GPC Biotech AG, or In
Europe: Brian Hudspith of Maitland, +44 (0)20 7379 5151, or
bhudspith@maitland.co.uk, or In the U.S.: David Schull of Russo
Partners, LLC, +1 212-845-4271, or
david.schull@russopartnersllc.com, both for GPC Biotech AG
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