NWBO to treat cancer, shares boosted higher by as much as 36% following declaring two special acceptances in Germany for its major immunotherapy product, DCVax-L.
As per reported by Northwest Biotherapeutics’ press release, under Germany’s hospital exemption, and through an approval from the Paul Ehrlich Institute (the equivalent of the Food and Drug Administration in Germany), hospitals can now give DCVax-L to patients with any kind of glioma brain cancers, whether they are recently diagnosed or recurrent, and the firm can charge complete price for these treatment outside of its ongoing phase 3 clinical studies.
On Monday late, Goldman lifted shares of InterMune (NASDAQ:ITMN) which were higher in Tuesday’s premarket session with 4.76%, referring to significant forecasts for Esbriet for IPF after higher than predicted to-line Phase III data in late February. The company views Esbriet as a transformative drug for IPF and views efficacy and aggressive concerns as overdone. Price target was lifted to $45 from $40.
Interim data from a late-stage trial of DCVax-L had been expected last month, but has not yet become available, causing concern among investors. The company declined to say when it will provide the interim data on the drug's safety and effectiveness. On Friday, it said an independent data safety monitoring board had recommended the trial continue, based on its safety review
Northwest Biotherapeutics plans to begin selling its drug in the next few months in Germany, and to ramp up production at its manufacturing plant in Leipzig, Powers said.
Separately, Germany's centralized government reimbursement authority has authorized Northwest Biotherapeutics to negotiate reimbursement for DCVax-L, Powers said. She added that six major hospital centers in Germany have applied to be eligible for reimbursement for the product, anticipating the hospital exemption.
Powers, through different investment entities that include venture capital firm Toucan Partners LLC and drug manufacturer Cognate BioServices Inc, owns 33 percent of Northwest Biotherapeutics' 51 million shares. Other major shareholders include Franklin Advisers Inc, The Vanguard Group and Goldman Sachs.
Reuters Shows Pics for DCvax Vials
1 of 3. A manufacturing associate holds a vial with a DCVax-L label in a Northwest Biotherapeutics laboratory in Memphis, Tennessee in this file photo taken February 21, 2014.
The tiny U.S. biotech received a special "hospital exemption" in Germany, allowing Northwest to sell the injectable drug for five years even though it has not completed its late-stage trial of the immunotherapy, Chief Executive Officer Linda Powers said in an interview. She said the company, which would also have the right to seek renewal of the exemption after five years, has not yet requested or received formal marketing approval for its product.
Northwest has attracted the interest of large institutional players such as Goldman Sachs
On March 10, 2014, Northwest Biotherapeutics, Inc. (NW Bio) announced that the Paul Ehrlich Institute (PEI - the FDA of Germany) has approved the Company of a 'Hospital Exemption' early access program under Section 4b of the German Drug Law. According to NW Bio, under the exemption, it may provide DCVax-L, outside of the Company clinical trial and charge full price to patients for the treatment of any glioma brain cancers, both newly diagnosed and recurrent. NW Bio also stated that the German reimbursement authority (Institut Für 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. Commenting on the approval, Linda Powers, CEO of NW Bio, stated, "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."
Approvals, Clinical Trial Results, - Analyst Notes on Northwest,
Remember present Mkt Cap is very low -to get atleast a $billion this has to $25
First interim analysis of its Phase III clinical trial in patients with Glioblastoma multiforme (GBM) brain cancer has been reached, and the analysis process is under way which will culminate in the independent Data Monitoring Committee’s assessment.
NW Bio receives recommendation to continue with Phase III GBM brain cancer trial based on the DSMB's Safety Review. Dr. Marnix Bosch states "We are pleased with the recommendation of the DSMB to continue the trial as planned. This is an important step in the ongoing progress of our Phase III tria
This early access approval goes substantially beyond the scope of the ongoing phase 3 trial which is studying DCVax-L only in newly diagnosed glioblastoma multiforme (grade IV glioma) patients. The exemption allows DCVax-L to be provided not only for this indication, but also for lower grade (less malignant) gliomas. It also extends beyond newly diagnosed gliomas (actually glioblastoma multiform) that are the focus of the phase 3 to include recurrent gliomas. The early access to DCVax allows patients to receive DCVax-L for all cases of glioma. This is stunning.
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Adam : I asked PEI.
"The Paul Ehrlich Institut signed the letter (Bescheid) on 14th February and we publish the approval in the Federal Gazette with date of 21th February. That is the date when the letter has been handed to Northwest Biotherapeutics," said PEI spokesperson Susanne Stoecker, in an email.