- DCVax-L Is First Product of Its Kind to Receive Hospital
Exemption from German Regulator
BETHESDA, Mayland, 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.
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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.
CONTACTS
Les
Goldman
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Farrell Kramer
(Media)
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202-841-7909
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212-710-9685
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lgoldman@nwbio.com
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Farrell.kramer@mbsvalue.com
|
|
|
Lisa Sher
(Investors)
|
|
212-661-2220
|
|
Lisa.Sher@mbsvalue.com
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