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MA(50) 1.45 and MA(200) 3.15 let's go for a nice ride here,VSTM
russian investors buying crazy here
VSTM HUGE DUDEEE<<“the Company”), today announced their entry into an exclusive licensing agreement with Sanofi to develop and commercialize Verastem Oncology’s COPIKTRA® (duvelisib), an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, for the treatment of all oncology indications in Russia and CIS, Turkey, the Middle East and Africa.
do your own dd ,end of story,my money -my call and I bought huge
Instead of pumping this news release why don't you share the entire story like fundamentals and financials of the company. Because in the end, that is all that matters.
lol shut up and buy or leave 2018 born
I have, $5M upfront + royalties on a disease that is rare. The drug is not a cure, only prolongs life. Revenues will not keep pace with their ongoing losses.
lol read the news haha 3-4 dollars today
Dude, this company lost $38M last quarter and has lost money since the start. This news, though good, doesn't warrant a big move up.
VSTM 1.57 in PM,UP 19%% BUY ASAP PEOPLE,volume pouring crazy,
VSTM~~could see 3-4 dollars tomorrow,crazy low float,will move hard
Verastem Oncology Signs an Exclusive License Agreement with Sanofi for the Development and Commercialization of COPIKTRA® (duvelisib) in Russia and CIS, Turkey, the Middle East and Africa
VTSM NEWS https://finance.yahoo.com/news/verastem-oncology-signs-exclusive-license-200500203.html
Can you elaborate more on your BO theory? $15-$20 a share? That sounds interesting!
Holy shit did I get that right!!!!!!!
VSTM 1.50 now,52wh at $10.35 dollars coming here people,read the monsta freaking news fast
VSTM~~MONSTA HUGE NEWS~~
Verastem Oncology Signs an Exclusive License Agreement with Sanofi for the Development & Commercialization of COPIKTRA® (duv...
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Verastem Oncology to Receive an Upfront Payment of $5 Million USD; Then Eligible to Receive Up To $42 Million USD in Development and Sales Milestones and Double-Digit Percentage Royalties
Sanofi Obtains Rights to Develop and Commercialize COPIKTRA in the Licensed Territories
Verastem, Inc. (NASDAQ: VSTM) operating as Verastem Oncology, (or “the Company”), today announced their entry into an exclusive licensing agreement with Sanofi to develop and commercialize Verastem Oncology’s COPIKTRA® (duvelisib), an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, for the treatment of all oncology indications in Russia and CIS, Turkey, the Middle East and Africa.
Under the terms of the agreement, Verastem Oncology shall receive an upfront payment of $5 million USD. Verastem Oncology is also eligible to receive up to an additional $42 million USD in development and sales milestone payments, plus double-digit percentage royalties based on future net sales of COPIKTRA in the licensed territories. Sanofi will receive exclusive rights to develop and commercialize COPIKTRA, and hold the marketing authorization and product license for COPIKTRA, in the licensed territories. Sanofi will also have the right to collaborate with Verastem Oncology on certain global development and clinical trial activities.
“Sanofi brings world-class capabilities in developing and commercializing products, making them an ideal partner to bring COPIKTRA to patients in these territories,” said Dan Paterson, President and Chief Operating Officer of Verastem Oncology. “Establishing this third partnership outside the U.S. validates the global potential of COPIKTRA and underscores our commitment to bring COPIKTRA to patients worldwide.”
David Khougazian, Head of Sanofi Genzyme, China & Emerging Markets, commented, “As a specialty care leader, we welcome partnerships that have the potential to bring value for patients and caregivers. This agreement adds to our pipeline an oncology medicine with an innovative mechanism of action and a significant potential of new hope for the patients suffering from those types of blood malignancies with high unmet medical need. Partnering with Verastem Oncology for the development and commercialization of COPIKTRA is consistent with our goals to deliver enhanced patient care and to expand our presence in oncology in Emerging Markets.”
COPIKTRA was approved in September 2018 by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. In addition, COPIKTRA has been granted accelerated approval by the FDA for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Accelerated approval in FL was based on overall response rate and continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. COPIKTRA includes a Boxed Warning for fatal and serious toxicities including infections, diarrhea or colitis, cutaneous reactions and pneumonitis. See full Prescribing Information for complete Boxed Warning and other important safety information.
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) is a commercial biopharmaceutical company committed to the development and commercialization of medicines to improve the lives of patients diagnosed with cancer. We are driven by the strength, tenacity and courage of those battling cancer – single-minded in our resolve to deliver new therapies that not only keep cancer at bay, but improve the lives of patients diagnosed with cancer. Because for us, it’s personal.
Our first FDA approved product is now available for the treatment of patients with certain types of indolent non-Hodgkin’s lymphoma (iNHL). Our pipeline comprises product candidates that seek to treat cancer by modulating the local tumor microenvironment. For more information, please visit www.verastem.com.
Verastem Oncology Forward Looking Statements
This press release includes forward-looking statements about Verastem Oncology’s strategy, future plans and prospects, including statements regarding the development and activity of Verastem Oncology’s lead product COPIKTRA, and Verastem Oncology’s PI3K program generally, its commercialization of COPIKTRA, the potential commercial success of COPIKTRA, the anticipated adoption of COPIKTRA by patients and physicians, the structure of its planned and pending clinical trials and the timeline and indications for clinical development, regulatory submissions and commercialization activities. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement.
Applicable risks and uncertainties include the risks and uncertainties, among other things, regarding: the commercial success of COPIKTRA in the United States; physician and patient adoption of COPIKTRA, including those related to the safety and efficacy of COPIKTRA; the uncertainties inherent in research and development of COPIKTRA, such as negative or unexpected results of clinical trials; whether and when any applications for COPIKTRA may be filed with regulatory authorities in any other jurisdictions; whether and when regulatory authorities in any other jurisdictions may approve any such other applications that may be filed for COPIKTRA, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted and, if approved, whether COPIKTRA will be commercially successful in such jurisdictions; our ability to obtain, maintain and enforce patent and other intellectual property protection for COPIKTRA and our other product candidates; the scope, timing, and outcome of any legal proceedings; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of COPIKTRA; the fact that regulatory authorities in the U.S. or other jurisdictions, if approved, could withdraw approval; whether preclinical testing of our product candidates and preliminary or interim data from clinical trials will be predictive of the results or success of ongoing or later clinical trials; that the timing, scope and rate of reimbursement for our product candidates is uncertain; that third-party payors (including government agencies) may not reimburse for COPIKTRA; that there may be competitive developments affecting our product candidates; that data may not be available when expected; that enrollment of clinical trials may take longer than expected; that COPIKTRA or our other product candidates will cause unexpected safety events, experience manufacturing or supply interruptions or failures, or result in unmanageable safety profiles as compared to their levels of efficacy; that COPIKTRA will be ineffective at treating patients with lymphoid malignancies; that we will be unable to successfully initiate or complete the clinical development and eventual commercialization of our product candidates; that the development and commercialization of our product candidates will take longer or cost more than planned; that we may not have sufficient cash to fund our contemplated operations; that we, Sanofi, CSPC Pharmaceutical Group, Yakult Honsha Co., Ltd. or Infinity Pharmaceuticals, Inc. will fail to fully perform under the duvelisib license agreements; that we may be unable to make additional draws under our debt facility or obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity, debt financing or otherwise; that we will not pursue or submit regulatory filings for our product candidates, including for duvelisib in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or indolent non-Hodgkin lymphoma (iNHL) in other jurisdictions; and that our product candidates will not receive regulatory approval, become commercially successful products, or result in new treatment options being offered to patients.
Other risks and uncertainties include those identified under the heading "Risk Factors" in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2019, as filed with the Securities and Exchange Commission (SEC) on May 9, 2019, its Annual Report on Form 10-K for the year ended December 31, 2018 as filed with the SEC on March 12, 2019 and in any subsequent filings with the SEC. The forward-looking statements contained in this press release reflect Verastem Oncology’s views as of the date hereof, and the Company does not assume and specifically disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190725005671/en/
Investors:
John Doyle
Vice President, Investor Relations & Finance
+1 781-292-4279
jdoyle@verastem.com
Media:
Lisa Buffington
Corporate Communications
+1 781-292-4205
lbuffington@verastem.com
VSTM~~52-Wk Range 1.16 - 10.35
VSTM~~1.56 now,,could see tomorrow 3-4 dollars run,WEEEEEE baby
VSTM~~WOWWW 1.50/1.54 ah going
VSTM looking great into tomorrow,should see $2.0+++
Verastem Oncology Signs an Exclusive License Agreement with Sanofi for the Development and Commercialization of COPIKTRA® (duvelisib) in Russia and CIS, Turkey, the Middle East and Africa
Thu July 25, 2019 4:05 PM|Business Wire|About: VSTM
Verastem Oncology to Receive an Upfront Payment of $5 Million USD; Then Eligible to Receive Up To $42 Million USD in Development and Sales Milestones and Double-Digit Percentage Royalties
Sanofi Obtains Rights to Develop and Commercialize COPIKTRA in the Licensed Territories
BOSTON--(BUSINESS WIRE)-- Verastem, Inc. (VSTM) operating as Verastem Oncology, (or “the Company”), today announced their entry into an exclusive licensing agreement with Sanofi to develop and commercialize Verastem Oncology’s COPIKTRA® (duvelisib), an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, for the treatment of all oncology indications in Russia and CIS, Turkey, the Middle East and Africa.
Under the terms of the agreement, Verastem Oncology shall receive an upfront payment of $5 million USD. Verastem Oncology is also eligible to receive up to an additional $42 million USD in development and sales milestone payments, plus double-digit percentage royalties based on future net sales of COPIKTRA in the licensed territories. Sanofi will receive exclusive rights to develop and commercialize COPIKTRA, and hold the marketing authorization and product license for COPIKTRA, in the licensed territories. Sanofi will also have the right to collaborate with Verastem Oncology on certain global development and clinical trial activities.
“Sanofi brings world-class capabilities in developing and commercializing products, making them an ideal partner to bring COPIKTRA to patients in these territories,” said Dan Paterson, President and Chief Operating Officer of Verastem Oncology. “Establishing this third partnership outside the U.S. validates the global potential of COPIKTRA and underscores our commitment to bring COPIKTRA to patients worldwide.”
David Khougazian, Head of Sanofi Genzyme, China & Emerging Markets, commented, “As a specialty care leader, we welcome partnerships that have the potential to bring value for patients and caregivers. This agreement adds to our pipeline an oncology medicine with an innovative mechanism of action and a significant potential of new hope for the patients suffering from those types of blood malignancies with high unmet medical need. Partnering with Verastem Oncology for the development and commercialization of COPIKTRA is consistent with our goals to deliver enhanced patient care and to expand our presence in oncology in Emerging Markets.”
COPIKTRA was approved in September 2018 by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. In addition, COPIKTRA has been granted accelerated approval by the FDA for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Accelerated approval in FL was based on overall response rate and continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. COPIKTRA includes a Boxed Warning for fatal and serious toxicities including infections, diarrhea or colitis, cutaneous reactions and pneumonitis. See full Prescribing Information for complete Boxed Warning and other important safety information.
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) is a commercial biopharmaceutical company committed to the development and commercialization of medicines to improve the lives of patients diagnosed with cancer. We are driven by the strength, tenacity and courage of those battling cancer – single-minded in our resolve to deliver new therapies that not only keep cancer at bay, but improve the lives of patients diagnosed with cancer. Because for us, it’s personal.
Our first FDA approved product is now available for the treatment of patients with certain types of indolent non-Hodgkin’s lymphoma (iNHL). Our pipeline comprises product candidates that seek to treat cancer by modulating the local tumor microenvironment. For more information, please visit www.verastem.com.
Verastem Oncology Forward Looking Statements
This press release includes forward-looking statements about Verastem Oncology’s strategy, future plans and prospects, including statements regarding the development and activity of Verastem Oncology’s lead product COPIKTRA, and Verastem Oncology’s PI3K program generally, its commercialization of COPIKTRA, the potential commercial success of COPIKTRA, the anticipated adoption of COPIKTRA by patients and physicians, the structure of its planned and pending clinical trials and the timeline and indications for clinical development, regulatory submissions and commercialization activities. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement.
Applicable risks and uncertainties include the risks and uncertainties, among other things, regarding: the commercial success of COPIKTRA in the United States; physician and patient adoption of COPIKTRA, including those related to the safety and efficacy of COPIKTRA; the uncertainties inherent in research and development of COPIKTRA, such as negative or unexpected results of clinical trials; whether and when any applications for COPIKTRA may be filed with regulatory authorities in any other jurisdictions; whether and when regulatory authorities in any other jurisdictions may approve any such other applications that may be filed for COPIKTRA, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted and, if approved, whether COPIKTRA will be commercially successful in such jurisdictions; our ability to obtain, maintain and enforce patent and other intellectual property protection for COPIKTRA and our other product candidates; the scope, timing, and outcome of any legal proceedings; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of COPIKTRA; the fact that regulatory authorities in the U.S. or other jurisdictions, if approved, could withdraw approval; whether preclinical testing of our product candidates and preliminary or interim data from clinical trials will be predictive of the results or success of ongoing or later clinical trials; that the timing, scope and rate of reimbursement for our product candidates is uncertain; that third-party payors (including government agencies) may not reimburse for COPIKTRA; that there may be competitive developments affecting our product candidates; that data may not be available when expected; that enrollment of clinical trials may take longer than expected; that COPIKTRA or our other product candidates will cause unexpected safety events, experience manufacturing or supply interruptions or failures, or result in unmanageable safety profiles as compared to their levels of efficacy; that COPIKTRA will be ineffective at treating patients with lymphoid malignancies; that we will be unable to successfully initiate or complete the clinical development and eventual commercialization of our product candidates; that the development and commercialization of our product candidates will take longer or cost more than planned; that we may not have sufficient cash to fund our contemplated operations; that we, Sanofi, CSPC Pharmaceutical Group, Yakult Honsha Co., Ltd. or Infinity Pharmaceuticals, Inc. will fail to fully perform under the duvelisib license agreements; that we may be unable to make additional draws under our debt facility or obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity, debt financing or otherwise; that we will not pursue or submit regulatory filings for our product candidates, including for duvelisib in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or indolent non-Hodgkin lymphoma (iNHL) in other jurisdictions; and that our product candidates will not receive regulatory approval, become commercially successful products, or result in new treatment options being offered to patients.
Other risks and uncertainties include those identified under the heading "Risk Factors" in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2019, as filed with the Securities and Exchange Commission (SEC) on May 9, 2019, its Annual Report on Form 10-K for the year ended December 31, 2018 as filed with the SEC on March 12, 2019 and in any subsequent filings with the SEC. The forward-looking statements contained in this press release reflect Verastem Oncology’s views as of the date hereof, and the Company does not assume and specifically disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
https://cts.businesswire.com/ct/CT?id=bwnews&sty=20190725005671r1&sid=acqr7&distro=nx&lang=en
View source version on businesswire.com: https://www.businesswire.com/news/home/20190725005671/en/
Investors:
John Doyle
Vice President, Investor Relations & Finance
+1 781-292-4279
jdoyle@verastem.com
Media:
Lisa Buffington
Corporate Communications
+1 781-292-4205
lbuffington@verastem.com
Source: Verastem, Inc.
Copyright Business Wire 2019
https://seekingalpha.com/pr/17583528-verastem-oncology-signs-exclusive-license-agreement-sanofi-development-commercialization
VSTM has been unusually quiet recently, and I suspect I know why. I keep adding those $1 1/17/20 calls cheeeeeeep!!
* * $VSTM Video Chart 07-11-2019 * *
Link to Video - click here to watch the technical chart video
That makes $5.250.000 revenue accountable for the 2Q. 2019 results?
* * $VSTM Video Chart 06-21-2019 * *
Link to Video - click here to watch the technical chart video
I gave up buying the regular stock, options pay better and require less capital.
I gave up on options on this especially after the latest news, just buying and trading shares on the open market makes it more interesting while holding a large core position.
LOL, I'm liking the bowering stats today.
https://iborrowdesk.com/report/VSTM
I thinks Verstem is a serious potential BO candidate, a pipeline drug with FDA approval and cash on hand. I keep trying to buy the $1 options, because a BO target is likely $15-$20 for the company at this point.
Remember each new script averages about $250,000 for 12 months on COPIKTRA™
https://investor.verastem.com/news-releases/news-release-details/verastem-oncology-presents-copiktratm-duvelisib-data-peripheral
* * $VSTM Video Chart 06-20-2019 * *
Link to Video - click here to watch the technical chart video
bought some 1/17/20 $1 calls here for $1, could be easy money if a BO occurs :)
Shares of many biotech companies have rallied following the announcement of the Pfizer PFE – Array BioPharma ARRY deal. Announced earlier this week, the deal has an enterprise value of approximately $11.4 billion. The deal is likely to strengthen Pfizer’s oncology portfolio as Array BioPharma is focused on developing targeted small molecule drugs for treating cancer and other high-burden diseases. Its first commercial therapy, Braftovi plus Mektovi, approved as a treatment for BRAF-mutant melanoma, was approved July last year and has shown encouraging uptake. Cancer has become the area of focus of several pharmaceutical companies due to unmet needs and lucrative market opportunities.
https://finance.yahoo.com/news/cancer-gene-therapy-biotechs-focus-152003662.html
Merck Seeks More Deals as It Expands Its Cancer Treatments Portfolio
By Jared S. Hopkins
June 19, 2019 5:30 am ET
Merck & Co. is searching for small and midsize deals, including more transactions aimed at expanding its portfolio of cancer treatments beyond the company’s top-selling product Keytruda, according to people familiar with the matter.
Merck has been buying cancer drugmakers with promising therapies and technologies. This month, Merck bought Tilos Therapeutics Inc. for $773 million. In May, it agreed to acquire Peloton Therapeutics Inc. for $1.1 billion.
The goal of the deal making is to both capitalize on the strength of Keytruda and further broaden the company’s non-oncology products, the people said. Merck is also interested in similarly sized deals that would add to its offerings of vaccines and animal-health medicines, the people said.
Drug pricing is complicated and secretive. WSJ explains how the flow of money, drugs and rebates behind the scenes may drive up the price of prescription medicine for consumers.
Keytruda, which unleashes a patient’s own immune system to fight tumors, was once an afterthought buried in Merck’s research-and-development pipeline but has in the past few years become a commercial juggernaut for the company.
The immunotherapy, whose approvals include treating 12 different types of tumors, rang up $7 billion in global sales last year and is projected to be the world’s top-selling drug by 2024, according to research firm EvaluatePharma.
Keytruda’s success has lifted Merck’s market capitalization to a record $217 billion. Since the company released positive study results for Keytruda in April 2018, Merck shares have risen 44%, compared with the S&P 500’s 9% gain.
Now some investors and analysts are starting to worry that Merck may be too dependent on Keytruda for growth. By 2024, Merck’s $20 billion in cancer-drug sales will be nearly 40% of company revenue, JPMorgan Chase & Co. projects. Merck also sells other prescription drugs, in addition to its vaccines and animal-health medicines.
“There is an emerging view, ‘Are they too tied to’” Keytruda, Credit Suisse AG analyst Vamil Divan said in an interview.
Among the likely topics is the company’s vaccines in development, including a potential competitor to Pfizer Inc.’s big-selling Prevnar vaccine, which protects against infections such as pneumonia and meningitis. JPMorgan analysts project Merck’s drug could reach sales of $1.5 billion.
Merck is also developing treatments for HIV/AIDS, chronic cough and heart failure.
The company is investing in its animal-health unit, which sells products for pets and livestock animals. In December, it acquired animal-tech company Antelliq Group for $2.4 billion. Merck is exploring Keytruda as a treatment for pets with cancer, according to a person familiar with the matter.
Yet outside of the company’s pipeline of cancer drugs, analysts haven’t been impressed with Merck’s drugs in development. Dr. Divan of Credit Suisse said the experimental drugs and vaccines target markets that other companies have struggled to succeed in or that are highly competitive.
“It’s up to them to show why they can do better than other companies have in these areas before,” Dr. Divan said.
Cancer, too, is a highly competitive market, which analysts and industry officials expect will get only more competitive as big drugmakers such as GlaxoSmithKline PLC try to build up a presence after staying away.
The intense interest has driven deal making in the sector—and raised premiums for cancer-drug startups. The latest deal came Monday, when Pfizer agreed to pay a 62% premium to buy Array BioPharma Inc. for $10.6 billion.
https://www.wsj.com/articles/merck-seeks-more-deals-11560936600
* * $VSTM Video Chart 06-18-2019 * *
Link to Video - click here to watch the technical chart video
* * $VSTM Video Chart 06-17-2019 * *
Link to Video - click here to watch the technical chart video
The SocialMedwork today:
Copiktra (duvelisib)
Copiktra (duvelisib) is a medication used for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and follicular lymphoma (FL) after at least two prior therapies.
How to buy Copiktra (duvelisib): You can order Copiktra (duvelisib) from TheSocialMedwork if the drug has not been approved or is not available in your country.
We provide access to newly approved medicines worldwide.
https://thesocialmedwork.com/pt/copiktra-duvelisib
From 2018
Impatient patients turn to online ‘buyers club’ for new drugs
KEY POINTS
Social Medwork sees its network as filling a gap in the market for the latest drugs against diseases such as cancer, migraine and multiple sclerosis.
In the past 18 months, the group has supplied more than 3,000 patients.
The Dutch group, which charges a fee of around 6 percent, claims to be the only organization focused on newly approved branded drugs.
Frustrated by delays in new medicines reaching their own country, a small but growing number of patients are turning to an online broker that bills itself as a legal version of the Dallas Buyers Club.
While regulators warn of the risk of buying drugs online, the Amsterdam-based Social Medwork sees its network of trusted suppliers as filling a gap in the market for the latest drugs against diseases such as cancer, migraine and multiple sclerosis.
Now it is looking to raise its profile and expand, by signing up former EU Commissioner Neelie Kroes to its supervisory board and securing 1.5 million euros ($1.73 million) in new funding from the Social Impact Ventures capital fund.
Like Ron Woodroof, the 1980s AIDS patient in the movie ‘Dallas Buyers Club’, patients who cannot get the drugs they want through local healthcare systems are using the organization to self-import medicines from abroad.
But while Woodroof had to smuggle drugs across the Mexican border, the Social Medwork’s customers can place orders online legally, as long as they have a prescription and a doctor’s letter stating that the drug is strictly for personal use.
In the past 18 months, the group, which is registered with the Dutch Ministry of Health as a medicines intermediary, has supplied more than 3,000 patients.
They include British migraine sufferer Senty Bera, 43, who recently used the system to buy Aimovig, a new monthly migraine injection from Amgen and Novartis, the first in an improved class of drugs that target a chemical involved in triggering attacks.
“My quality of life was so poor I thought it was worth trying and it is working brilliantly,” Bera said.
As yet, Aimovig is not approved for use within Britain’s state health service - though Bera hopes it will be soon - but its reputation means it is one of Social Medwork’s top-sellers, despite a price tag of 698 euros for two autoinjectors.
A spokeswoman for Britain’s Medicines and Healthcare products Regulatory Agency confirmed there were no formal restrictions on importing such medicines for personal use.
In the past, informal drug-buying networks here have helped supply cheap generic versions of treatments for HIV and hepatitis C. But the Dutch group, which charges a fee of around 6 percent, claims to be the only organization focused on newly approved branded drugs.
With customers in 70 countries, its line-up includes new cancer drugs that are U.S.-approved but not yet available elsewhere, as well as medicines for chronic disorders, such as Roche’s new multiple sclerosis treatment Ocrevus.
Founder Sjaak Vink says the Internet means patients are increasingly aware they may be waiting months or even years for novel drugs following a first approval elsewhere.
“We really need to bridge this gap because this situation is ridiculous,” he said in an interview.
Vink said he was inspired to found the organization by delays in European availability of Merck’s innovative cancer immunotherapy Keytruda.
Today, his group has customers in Australia, the Middle East and Asia, as well as major European markets such as France, Italy, Germany and Britain, where drug delays could worsen if Brexit disrupts supply lines.
Given relatively speedy U.S. approvals, there are currently fewer customers in America, although there was a spike in U.S. demand last year for Mitsubishi Tanabe Pharma’s amyotrophic lateral sclerosis drug Radicut/Radicava, which was approved first in Japan.
https://www.cnbc.com/2018/10/03/impatient-patients-turn-to-online-buyers-club-for-new-drugs.html
* * $VSTM Video Chart 06-14-2019 * *
Link to Video - click here to watch the technical chart video
Duvelisib, an oral dual PI3K-d,? inhibitor, efficacy and safety in patients with relapsed or refractory (RR) peripheral T-cell lymphoma: rationale for the phase 2 PRIMO trial
S.M. Horwitz F.M. Foss P. Porcu A. Moskowitz N. Mehta-Shah E. Jacobsen M.S. Khodadoust Y.H. Kim D. Weinstock S. Lustgarten M. Baglio H. Youssoufian J. Brammer
First published: 12 June 2019 https://doi.org/10.1002/hon.33_2629
ePDFPDFTOOLS SHARE
Background: RR PTCL is associated with a poor prognosis, with most therapies inducing responses in <30% of pts and median progression-free survival (PFS) <4 mo. Phosphoinositide-3-kinase (PI3K) pathway has a role in survival and proliferation of malignant T cells, as well as T-cell receptor and cytokine signaling in nonmalignant T cells. Duvelisib (DUV), an oral dual PI3K-d-? inhibitor, exhibited potent activity against T-cell lymphoma (TCL) cell lines in vitro and reprogrammed tumor-associated macrophages from the immunosuppressive M2-like phenotype to the inflammatory M1-like phenotype (Horwitz, Blood 2018). DUV monotherapy 25 mg BID is FDA approved for the treatment of RR CLL/SLL in pts who have received ≥2 lines of prior therapy and RR follicular lymphoma in pts who have received ≥2 lines of prior systemic therapy. The optimal dose of DUV in TCL is undefined. Here we summarize the safety and activity of DUV in pts with RR PTCL from 2 phase 1 studies that support the rationale for the ongoing phase 2 PRIMO study (NCT03372057).
Methods: In the initial phase 1 study (NCT 01476657), pts with RR PTCL received DUV until progression or intolerance, as part of a dose-escalation phase. In a separate phase 1 study (NCT02783625), pts with RR PTCL received DUV 25 mg or 75 mg BID as monotherapy for 1 mo as a lead-in to a combination regimen with either romidepsin (R) or bortezomib (B).
Results: A total of 29 pts with RR PTCL received DUV in the phase 1 studies. Among pts who received the DUV 75-mg dose as monotherapy or lead-in therapy before R, the ORR was 54% and 44%, with CR rates of 15% to 22%, respectively (Table). Notably, ORR was 57% among pts receiving lower dose of DUV (25 mg BID) as lead-in therapy before B. Pts receiving DUV as lead-in had a response at the end of cycle 1. In the phase 1 escalation study, response to DUV typically occurred by the first assessment (cycle 2) and was observed across a spectrum of PTCL subtypes. Two pts who attained a CR and PR, respectively, in the phase 1 escalation study completed >1 year of DUV treatment (Horwitz, Blood 2018). The preliminary safety profile of DUV in pts with PTCL was considered reasonable and consistent with previous reports.
Conclusions: DUV 25 or 75 mg BID demonstrated encouraging clinical activity and an acceptable safety profile in RR PTCL, a population in need of new and effective therapies. The ongoing phase 2 PRIMO study dose optimization phase will identify the optimal regimen of DUV monotherapy in RR PTCL and characterize the efficacy and tolerability of DUV in ˜100 pts.
Disclosures: Horwitz, S: Consultant or Advisory Role: ADCT Therapeutics, Aileron, Forty-Seven, Infinity/Verastem, Kyowa-Hakka-Kirin, Millennium /Takeda, Seattle Genetics, Affimed, Angimmune, Beigene, Corvus, Innate Pharma, Kura, Merck, Miragen, Mundipharma, Portola, Syros Pharmaceutical; Research Funding: ADCT Therapeutics, Aileron, Forty-Seven, Infinity/Verastem, Kyowa-Hakka-Kirin, Millennium/Takeda, Seattle Genetics, Celgene, Trillium. Porcu, P: Consultant or Advisory Role: Innate Pharma, Miragen, Kiowa, Viracta, Seattle Genetics, Beigene; Honoraria: Innate Pharma, Miragen, Kiowa, Viracta; Research Funding: Kura Pharmaceuticals. Moskowitz, A: Honoraria: Kyowa Hakko Kirin Pharma, Miragen Therapeutics, Takeda Pharmaceuticals, ADC Therapeutics, Seattle Genetics, Cell Medica, Bristol-Myers Squibb, Erytech Pharma; Research Funding: Seattle Genetics, Merck, Bristol-Myers Squibb, Incyte. Mehta-Shah N: Consultant or Advisory Role: Kyowa-Hakka-Kirin; Research Funding: Celgene, Verastem, Bristol Myers Squibb, Genentech/Roche. Jacobsen E: Consultant or Advisory Role: Bayer; Honoraria: Seattle Genetics, Merck, Takeda, Astra-Zeneca; Research Funding: Novartis, Hoffman-LaRoche, Pharmacyclics, Merck, Celgene, Seattle Genetics. Khodadoust M: Consultant or Advisory Role: Kyowa Kirin, Inc.; Seattle Genetics. Weinstock D: Research Funding: Verastem. Lustgarten S: Employment or leadership position: Verastem; Stock ownership: Verastem. Baglio M: Employment or leadership position: Verastem; Stock ownership: Verastem. Youssoufian H: Employment or leadership position: Verastem (Head, Medical Strategy); Stock ownership: Verastem.
https://onlinelibrary.wiley.com/doi/10.1002/hon.33_2629
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