Good news is not always great news that makes a difference. In the drug industry, clinical trial results that demonstrate a drug has fulfilled the requirements of the trials, including the primary and secondary endpoints does not always guarantee that the drug will be successful if and when it hits the market. Experience and follow up on certain firms enables us to see the real light at the end of the tunnel, not just celebrate reaching the end of it without knowing what to expect outside. This makes a big difference.
The following are drugs we believe will add enormous value to their developing firms.
Takeda Pharmaceutical Limited (TKPYY), which collaborates with Seattle Genetics (SGEN) on ADCETRIS (brentuximab vedotin) received marketing authorization from the European Commission. The marketing authorization is specifically for adult patients with CD30+ Hodgkin lymphoma (HL) who are at increased risk of relapse or progression following autologous stem cell transplant (ASCT).
The approval is based on a phase 3 clinical trial called AETHERA that was designed to compare up to 16 cycles (approximately one year) of ADCETRIS therapy administered every three weeks following ASCT to placebo.
This label expansion represents the third indication for Adcetris in the European Union (EU), and follows the FDA approval in August 2015 for a similar label based on the AETHERA clinical trial.
With this additional approval, Adcetris becomes the first and only consolidation treatment in both the United States and European Union for high risk classical Hodgkin lymphoma patients to preserve their remission post-transplant.
Adcetris seems on its way to become the global foundation of therapy for classical Hodgkin lymphoma and CD30-expressing lymphomas.
What does this mean?
It means an important advancement made for patients with classical Hodgkin lymphoma (HL) and CD30-expressing lymphomas. It means a lot at the level of Adcetris’ revenue growth, knowing in fact that the conditional marketing authorization for Adcetris is valid in the 28 member states of the EU as well as Norway, Liechtenstein and Iceland.
Adcetris is an antibody drug conjugate (ADC) targeting CD30. The monoclonal antibody is attached by a protease-cleavable linker to a microtubule disrupting agent, mono-merthyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. A linker system is designed to be stable in the bloodstream but releases the disrupting agent MMAE upon internalization into CD30-expressing tumor cells.
The FDA has approved Adcetris for the following three indications:
(1) Regular approval for the treatment of patients with classical HL after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates,
(2) Regular approval for the treatment of classical HL patients at high risk of relapse or progression as post-auto-HSCT consolidation, and;
(3) Accelerated approval for the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen.
In October 2012, the European Commission granted Adcetris conditional marketing authorization for the following two indications:
(1) The treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.
(2) The treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).
In January 2016, the European Commission approved a Type II variation to include data on the retreatment of adult patients with Hodgkin lymphoma or sALCL who previously responded to Adcetris and who later relapse.
In June 2016, the European Commission extended the current conditional approval of Adcetris and approved Adcetris for the treatment of adult patients with CD30+ Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplant (ASCT). See important safety information below.
The Collaboration Agreement
Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize Adcetris in the rest of the world.
Seattle Genetics and Takeda are funding joint development costs for Adcetris on a50:50 basis, except in Japan where Takeda is solely responsible for development costs.
Seattle Genetics has strong scientific fundamentals, incredible and evolutionary monoclonal antibody conjugate technology (ADC) and immense experience.
The management is first class and is doing whatever it takes to make this firm become part of the top-tier biopharmaceutical firms. We sincerely believe that Seattle Genetics antibody drug conjugate (ADC) products are playing and will continue to play a big role as a monotherapy and in combination with the novel cancer immunotherapy products.
The stock price, we believe, is still being manipulated by news about incidents that have nothing to do with the firm’s technological capabilities, pipeline products or future growth. That’s why we reiterate our opinion that the current SGEN’s market cap is way undervalued. Getting out of the European Union, the decision made by the British people that favors a divorce rather than the status quo might affect SGEN and all biotech companies
and all other industries’ firms. But such external events, we believe, would cause a selloff of a short-duration in otherwise great performing firms.
SGEN has all the necessary elements for fostering its future growth. Its ADC technology is most needed right now. Many oncologists believe this firm’s ADC technology will have an increasing role to play in combination with the new emerging immunotherapy checkpoint inhibitors and other immunotherapy drugs.
That’s why we are in for SGEN. We consider SGEN’s market cap way undervaluedcompared to the firm’s worth in real life far away from the market’s speculation, manipulation and daily trading, including the recurrent buying and selling by professional frequent everyday traders.
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The European Commission (EC) approved a variation of the marketing authorization for Amgen’s (AMGN) drug Kyprolis® (carfilzomib). The variation includes using the second-generation proteasome inhibitor Kyprolis® in combination withdexamethasone for adult patients with multiple myeloma who received at least one prior therapy.
Kyprolis-approved variation regimens have shown superiority over standard-of-care treatment options for relapsed multiple myeloma patients, reinforcing Kyprolis’ place as a foundational therapy in this patient population.
Data from Phase 3 head-to-head ENDEAVOR trial in patients with multiple myeloma treated with Kyprolis plus dexamethasone (Kd) achieved superior progression-free survival (PFS) of 18.7 months compared to 9.4 months in those receiving bortezomib plus dexamethasone.
The combination Kyprolis + dexamethasone also demonstrated significantly longer progressive-free survival (PFS), which was seen in pre-specified subgroups, including:
– Bortezomib-naive patients,
– Patients with high- or standard-risk cytogenetics and;
– Patients with or without prior transplantation.
In terms of secondary endpoints, Kyprolis + dexamethasone (Kd) achieved a higher Overall survival (OS).
However, data are not yet mature and continue to be monitored.
Kyprolis® (carfilzomib): Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed. Kyprolis has been shown to block proteasomes, leading to an excessive build-up of proteins within cells. In some cells. Kyprolis can cause cell death especially in myeloma cells because they are more likely to contain a higher amount of abnormal proteins.
Kyprolis is approved in the U.S. for the following:
In combination with dexamethasone or with lenalidomide plus dexamethasone for
– Patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
– As a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.
Kyprolis is also approved in the following countries: Argentina, Israel, Kuwait, Mexico, Thailand, Colombia, Korea, Canada, Switzerland, Russia, Brazil and the European Union. Additional regulatory applications for Kyprolis are underway and have been submitted to health authorities worldwide.
For more U.S. information, please visit www.kyprolis.com.
Important EU Product Safety Information
In the upcoming Prohost Letter #397, you will read about many good news occurring simultaneously at Amgen (AMGN). Each one of the news contributes to the firm’s future growth that you never believe they happened and continue to happen now while the stock price is left to yoyo in between the hands with fingers that sells at any profits made and buy after they themselves have devastated the stock, in addition to exhausting the sincere shareholders.
Our repeated saying what we believe in, which is when this kind of boxing occurs against great achieving firms, it comes a time when the boxed stocks destroy their boxes and demonstrate how they are giants, but were looking as dwarfs by being imprisoned in a cell that’s half or less than half their real sizes.
We are expecting this rebound to happen to Amgen and other firms in our portfolio. It it will be all cited in the Prohost Letter #397, which will be posted in early next week.
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An Agreement that Could Make a Difference
On June 8, Takeda signed a global licensing, development and commercialization deal with Theravance Biopharma (TBPH) to develop TD-8954.
TD-8954 is a drug to treat gastrointestinal motility disorders, including enteral feeding intolerance. That drug is currently in Phase II trials. The deal could bring in more than $125 million for Theravance. (More elaboration and analysis will be published in Prohost Letter #397).
Regeneron Pharmaceuticals (REGN) and Sanofi announced Japan granted marketing and manufacturing authorization for Praluent® (alirocumab) for uncontrolled low-density lipoprotein (LDL) cholesterol, in certain adult patients with hypercholesterolemia at high cardiovascular risk.
Praluent is a human monoclonal antibody targeting
Proprotein convertase subtilisin/kexin type 9 (PCSK9).
In Japan, Praluent is indicated for people with hypercholesterolemia and familial hypercholesterolemia (FH) who are at high cardiovascular risk. It is indicated also for people in whom treatment with statins (HMG-CoA reductase inhibitors) is not doing the job as required.
Praluent 75 mg and 150 mg will be available in Japan as a single-dose pre-filled pen and syringe.
The drug is very important for the Japanese, as hypercholesterolemia is a significant concern in this country and many patients are not able to achieve their LDL cholesterol treatment goals with currently available statins. The Japanese market will definitely contribute to a conspicuous increase in Regeneron’s revenues.
Data from clinical trials assure that the drug works better than the existing ones. Phase 3 ODYSSEY trials showed consistent, robust reductions in LDL cholesterol for Praluent compared to placebo, when added to current standard- which included maximally-tolerated statins. The Phase 3 ODYSSEY JAPAN confirmed the safety and efficacy of Praluent 75 mg starting dose every two weeks on Japanese patients with primary hypercholesterolemia and elevated LDL cholesterol.
Patients who did not achieve their pre-specified LDL cholesterol goals with Praluent 75 mg at week 8 were increased to Praluent 150 mg every two weeks at week 12.
In the ODYSSEY JAPAN trial, Praluent reduced LDL cholesterol by 63 percent at week 24 on top of stable background statin therapy, compared to a 2 percent increase in the placebo group.
Patients treated with Praluent maintained their LDL cholesterol reductions for the duration of the trial. By week 52, patients in the Praluent group achieved an average LDL cholesterol of 53.4 mg/dL, compared to an average LDL cholesterol of 135.6 mg/dL (in the placebo group.
Praluent is also approved in the United States, European Union, Canada and Mexico. The effect of Praluent on cardiovascular morbidity and mortality has not yet been determined.
Regeneron’s pipeline guarantees the firm’s revenues growth for years to come. Important to note that this firm’s technologies are behind the fact that its products are safer and more effective than similar products approved for other competing firms. That’s what makes this firm great and makes us predict a successful outcome of clinical trials of Regeneron’s pipeline of investigational products.
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