BETHESDA, Md., March 10, 2014 /PRNewswire/ -- Northwest
Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company
developing DCVax® personalized immune therapies for solid tumor
cancers, announced today that it has received approval from the
Paul Ehrlich Institute ("PEI"- the FDA of Germany) of a "Hospital Exemption" early
access program under Section 4b of the German Drug Law. Under
this Hospital Exemption, NW Bio may provide DCVax-L to patients for
the treatment of any glioma brain cancers (both Glioblastoma
multiforme and lower grade gliomas), both newly diagnosed and
recurrent, outside of the Company's clinical trial and charge full
price. The patients may be from Germany or elsewhere. This approval has
a term of five years, and can be re-applied for and re-issued at
the end of that period.
NW Bio also announced today that the German reimbursement
authority (Institut Fur Das Entgeltsystem Im Krankenhaus, or InEK)
has determined that DCVax-L treatments for glioma brain cancers are
eligible to obtain reimbursement from the Sickness Funds (health
insurers) of the German healthcare system. Applications for
such reimbursement eligibility may only be submitted to InEK by
German hospitals, not by a company. Six major hospital
centers across Germany applied for
such reimbursement eligibility for DCVax-L for glioma brain
cancers. The amount and terms for such reimbursement will now
be negotiated by NW Bio, the hospitals and the Sickness Funds over
the coming months, and will be applied to patients case by
case. In the meantime, patients may self-pay for DCVax-L.
The approval of the Hospital Exemption for DCVax-L is the
culmination of nearly two years of regulatory processes and
scrutiny, starting with a Scientific Advice process during 2012,
and followed by an application for Hospital Exemption in December,
2012. The evaluation of NW Bio's application by the German
regulatory authorities included comprehensive and detailed scrutiny
of all aspects of the DCVax-L technology, all DCVax-L clinical data
to date, all manufacturing processes, all product characteristics
(including potency, composition, sterility and other aspects), all
frozen storage of DCVax-L and frozen shelf life, and all
distribution and handling of the DCVax-L products.
Although Section 4b of the German Drug law for Hospital
Exemptions was implemented in July
2011, the approval for DCVax-L is the first such approval
granted by the German regulatory authorities in multiple key
ways. Only two prior approvals have been given in the more
than 2-1/2 years since the law was put in place, and those were for
two German companies with tissue engineered products which had
already been on the market commercially under prior laws and were
grandfathered for regulatory purposes, and which did not have
pharmacological (i.e., drug-like) effects in the patient's
body.
In contrast, DCVax-L is the first product of its kind to receive
Hospital Exemption approval from the German regulators, in the
following key ways:
- the first immunotherapy;
- the first product which exerts pharmacological (i.e.,
drug-like) effects in the patient's body;
- the first product that has never previously been on the market
commercially;
- the first product developed by a non-German company, not
previously under the German regulators' oversight; and
- the first "somatic" cell therapy product (a somatic cell is any
cell of the body other than a reproductive or embryonic cell).
Furthermore, the scope of the Hospital Exemption granted for
DCVax-L is broader than the scope of NW Bio's ongoing Phase III
clinical trial (which must focus on a homogeneous set of patients
in order to produce data that can be compared between treated and
control patients). The Hospital Exemption for DCVax-L applies
to all glioma brain cancers, including both the most severe grade
(Grade IV, Glioblastoma multiforme or GBM) and lower grade gliomas,
while the clinical trial includes only GBM. The Hospital
Exemption also includes both newly diagnosed and recurrent gliomas,
while the clinical trial includes only newly diagnosed.
Based upon data from the German Brain Tumor Association, there
are approximately 7,000 new cases of gliomas (primary brain
cancers) per year in Germany. These would include
approximately 3,000 cases of Glioblastoma multiforme (GBM), the
most severe grade of glioma (Grade IV).
DCVax-L products that are to be covered by the Hospital
Exemption in Germany must be
manufactured in Germany, but can
be administered to patients from anywhere. As in the
Company's clinical trial, DCVax-L will be administered under the
Hospital Exemption as an adjuvant treatment after surgical removal
of the tumor and radiation/chemotherapy where applicable. The
Company will provide annual data reports to the German regulatory
authority during the five-year term of the Hospital
Exemption.
The Company expects to activate this program over the coming
months.
"We are grateful to the PEI and InEK for these important
decisions enabling DCVax-L to be made available to brain cancer
patients now, and enabling reimbursement to be arranged with the
Sickness Funds," commented Linda
Powers, CEO of NW Bio. "We are also excited about the
validation of our DCVax-L technology and our manufacturing,
infrastructure and systems after such exhaustive scrutiny and
evaluation by one of the toughest regulatory authorities.
Patients will now have a promising new treatment option, and the
Company will have an invaluable opportunity to begin practicing now
for commercial operations in the future."
Prof. Dr. Frank Emmrich, the
Director of Fraunhofer IZI, commented: "This PEI decision,
granting the Hospital Exemption approval to DCVax-L has achieved
many 'firsts' and is a historic milestone. Fraunhofer IZI is
pleased to be part of the strong Team that achieved this approval,
and we look forward to helping implement this much needed
program."
Dr. Zaklina Buljovcic, the
Regulatory Expert on Innovative Therapies, of PharmaLex GmbH
commented: "We at PharmaLex are very happy and excited that a
somatic cell therapy for glioma has received the first Hospital
Exemption approval in Germany for
a new product. We also think that this approval is
encouraging for universities and companies developing other cell
therapies. Overall, it was great teamwork, and we appreciate the
good cooperation with all parties involved, including the PEI."
As a follow-up to this announcement, the Company will
periodically provide further information about its Hospital
Exemption program and reimbursement as the information becomes
available. Patients, physicians and others who would like to
make inquiries about the program may do so using the following
email addresses, or may contact the Contact Persons listed
below.
- patients@nwbio.com
- physicians@nwbio.com
- investors@nwbio.com
- media@nwbio.com
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on
developing immunotherapy products to treat cancers more effectively
than current treatments, without toxicities of the kind associated
with chemotherapies, and on a cost-effective basis, in both
the United States and
Europe. The Company has a broad platform technology for DCVax
dendritic cell-based vaccines. The Company's lead program is
a 312-patient Phase III trial in newly diagnosed Glioblastoma
multiforme (GBM). GBM is the most aggressive and lethal form
of brain cancer, and is an "orphan disease." The Company is
under way with a 60-patient Phase I/II trial with DCVax-Direct for
all inoperable solid tumors cancers, with a primary efficacy
endpoint of tumor regression. The Company previously received
clearance from the FDA for a 612-patient Phase III trial in
prostate cancer. The Company conducted a Phase I/II trial
with DCVax for metastatic ovarian cancer together with the
University of Pennsylvania.
Disclaimer
Statements made in this news release that are not historical
facts, including statements concerning future treatment of patients
using DCVax and future clinical trials, are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Words such as "expect," "believe,"
"intend," "design," "plan," "continue," "may," "will,"
"anticipate," and similar expressions are intended to identify
forward-looking statements. Actual results may differ
materially from those projected in any forward-looking
statement. Specifically, there are a number of important
factors that could cause actual results to differ materially from
those anticipated, such as risks related to the Company's ability
to raise additional capital, risks related to the Company's ability
to enroll patients in its clinical trials and complete the trials
on a timely basis, uncertainties about the clinical trials process,
uncertainties about the timely performance of third parties, risks
related to whether the Company's products will demonstrate safety
and efficacy, risks related to the Company's and Cognate's
abilities to carry out the intended manufacturing expansions
contemplated in the Cognate Agreements, risks related to the
Company's ability to carry out the Hospital Exemption program and
risks related to possible reimbursement and pricing.
Additional information on these and other factors, including Risk
Factors, which could affect the Company's results, is included in
its Securities and Exchange Commission ("SEC") filings.
Finally, there may be other factors not mentioned above or included
in the Company's SEC filings that may cause actual results to
differ materially from those projected in any forward-looking
statement. You should not place undue reliance on any
forward-looking statements. The Company assumes no obligation
to update any forward-looking statements as a result of new
information, future events or developments, except as required by
securities laws.
Logo -
http://photos.prnewswire.com/prnh/20110329/SF73084LOGO
CONTACTS
Les
Goldman
|
Farrell Kramer
(Media)
|
202-841-7909
|
212-710-9685
|
lgoldman@nwbio.com
|
Farrell.kramer@mbsvalue.com
|
|
|
Lisa Sher
(Investors)
|
|
212-661-2220
|
|
Lisa.Sher@mbsvalue.com
|
|
SOURCE Northwest Biotherapeutics, Inc.