Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Treatment of HER2-postive breast cancer
November 22, 2016
By Amy Yip, BioSpace.com Contributor
The National Institute for Clinical Excellence (NICE), the UK’s drug watchdog, has finally given its backing for the National Health Service’s (NHS’s) approval of Roche (RHHBY)’s Perjeta (pertuzumab) for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
Three years after its initial approval by both the FDA and the European Medicines Agency (EMA), the HER2-targeting monoclonal antibody is being recommended by NICE for use in combination with Genentech (RHHBY)’s Herceptin (trastuzumab) + docetaxel for the neoadjuvant treatment of HER2-postive breast cancer. Notably, this will be the first new breast cancer drug to be approved by NICE for routine NHS funding in almost a decade.
During the last ten years, the cost of Perjeta has been covered by the recently remodelled Cancer Drugs Fund (CDF). In most Western markets, the combination of Perjeta + Herceptin + docetaxel has become the new standard of care for the first-line treatment of HER2-postive breast cancer. NICE initially declined to support Perjeta’s approval in 2013 for the first-line treatment of metastatic HER2-positive breast cancer, and then declined again in May 2016 for Perjeta’s use in the neoadjuvant setting, based on a lack of proven cost-effectiveness due to the high cost of treatment and lack of data on the long-term patient benefit.
At the time, NICE issued a statement that said due to its combination with Herceptin in the first-line metastatic setting and the resulting increased duration of treatment, Perjeta, even when priced at $0, was not cost-effective enough to necessitate approval.
This refusal has since gained notoriety as an example of the drawbacks of health technology assessment and cost-effectiveness analyses in the assessment of new cancer drugs. NICE’s cost-effectiveness assessment thresholds have been criticised as being archaic and poorly adapted to the challenge of fairly and accurately assessing the benefits of modern cancer therapies.
Despite mounting controversy regarding its decision about Perjeta, NICE continued to resist the drug’s approval, stating that the uncertainties surrounding Perjeta use on long-term, real-world survival meant that the agency could not recommend it as a cost-effective use of state funds. However, with Roche’s new pledge to provide the drug to the NHS at an undisclosed discount for patients in the neoadjuvant setting and to share the long–term financial risks, the two parties have finally come to an agreement.
Perjeta’s widespread adoption has been based on the results of the Phase III CLEOPATRA study released in 2013, where treatment with the triple combination extended patient progression free survival by more than six months, compared to Herceptin + docetaxel alone (18.5 months versus 12.4 months). Overall survival data also indicated that the triple combination reduced the risk of death by 34% compared to Herceptin + docetaxel alone.
Hayword that was me unloading some in the PRE this morning.
30K pushed it down a bit.
BREAKING DOWN 'SEC Form NT 10-Q'
The form 10-Q is required to be filed within 45 days following the end of each of a company's first three fiscal quarters. If the 10-Q cannot be filed in a timely manner, the company must file a Form 10-QT with the commission. A very common reason for an NT 10-Q is a merger or acquisition, which prevents results from being incorporated in time for the filing. The SEC provides for "unreasonable effort and expense", with explanation, as part of the application for relief.
May be related to this:
Immune is also moving forward with forming three private companies separate from the development of bertilimumab, focusing on Immuno-Oncology, Dermatology, and Pain & Neurology respectively. The Immuno-Oncology subsidiary will focus on Ceplene, which recently received guidance from the FDA for a pivotal phase 3 Overall Survival study in remission maintenance for Acute Myeloid Leukemia, and novel bispecific antibodies targeting immune check points and other novel targets. The Dermatology subsidiary will focus on the application of nanotechnology to dermatology. The lead program is a topical cyclosporine for the treatment of psoriasis and atopic dermatitis. The Pain and Neurology subsidiary will focus on AmiKet(r) for the treatment of peripheral neuropathic pain with the subsidiarys new management looking at complementary assets.
Read more: SEC Form NT 10-Q Definition | Investopedia http://www.investopedia.com/terms/s/sec-form-nt-10-q.asp#ixzz4QH7xDBUl
Follow us: Investopedia on Facebook
Glad to see this word cropping up again. "Imminent"
Triple combination treatments will be the way forward.
Importantly, the improved anti-tumor activity seen in these studies was even greater when PS-targeting therapy was a part of triple combination treatment including anti-PD-1 and another therapy. Data were presented by Peregrine scientists, as well as researchers from Memorial Sloan Kettering Cancer Center (MSK), at the Society for Immunotherapy of Cancer (SITC) 2016 Annual Meeting, which was held November 9-13, 2016 in National Harbor, MD.
A second study, conducted by Peregrine, evaluated the effects of combining PS-targeting, anti-PD-1 and anti-LAG3 therapies in the E0771 triple negative breast cancer (TNBC) model. Initial findings from this study were previously reported and demonstrated that eight of the ten (80%) animals receiving the PS-targeting, anti-PD-1 and anti-LAG3 treatment combination experienced complete tumor regressions, whereas there were no animals (0/10) in the anti-PD-1 and anti-LAG3 combination treatment arm that had a complete regression. New data presented for the first time at SITC demonstrated that the triple combination established a specific and prolonged anti-tumor immune response which protected those eight animals that achieved a complete tumor regression against a re-challenge with the same E0771 TNBC model tumor cells. This sustained anti-tumor response demonstrates the ability of the triple combination treatment to trigger immune system memory and support adaptive immune responses against reemerging disease in the E0771 TNBC model.
Ok I believe this has been discussed below already but....
I take it to mean what it states. Median survival surpasses 80 days and counting for triple treatment.
Median survival for the triple combination treatment still had not been reached at the end of the 80-day observation period with other arms in the study showing median survival that ranged from 24-70 days.”
Wow. You heard it here. Longs hoping you're right.
Nice except for 1/20 RS!
"Imminent" is a nice word coming soon into PPHM vocabulary.
Perhaps minor move on SEC Filling Q10 if surprise estimate? Otherwise RS coming in December for Nasdaq compliance.
Pipeline years away still.
Possible partnership play with Ceplene within next two years.
Loof Maybe if you ship SK some of that corn licker things will get stirred up a bit.
Perhaps another Jazz Pharmaceuticals will be in the making. IMNP was comparable in focus as mentioned in interview then expanded through partnership to present $114.00 PPS. Need to line up partnership.
Partnerships historically happen in Phase 111.
(NASDAQ:IMNP), after the company announced its plan to submit the final protocol for an international pivotal Phase III trial of Ceplene in combination with low-dose IL-2 for the remission maintenance of acute myeloid leukemia (AML) patients.
Bernardino wrote, “The decision was based on the FDA’s latest guidance received by Immune regarding Ceplene’s future regulatory pathway in the U.S. The new Phase III trial design, which Immune intends to submit in early 2017, will measure overall survival (OS) as the primary endpoint.
Trump has stated he wanted to make it easier to get badly needed drugs approved and pushed through the FDA more expediently. Let's see what happens.
Businessman's acumen at the White House could change the pace of drug approvals.
I am about 24 miles or so away but will not make it this go.
Loof Best advice on the board by far. IMHO
Yes been a long stretch for longs. BOD needs to dangle some carrots.
Looks a little cheaper already. Not surprised.
I filled 30K @.337
NASDAQ Grants Extension To Immune Pharmaceuticals Inc. To Regain Compliance With Requirements Under NASDAQ Listing Rule 5810(c)(3)
Jul 6 16
On July 6, 2016, Immune Pharmaceuticals Inc. received a notification from the Listing Qualifications Department of The NASDAQ Stock Market LLC (NASDAQ) indicating that the company had been granted an additional 180 calendar day extension, or until January 3, 2017, to regain compliance with the requirements under NASDAQ Listing Rule 5810(c)(3). The notification stated that Extension determination was based on the company meeting the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on the Capital Market, with the exception of the bid price requirement. The notification has no immediate effect on the NASDAQ listing or trading of the company’s common stock. As previously reported on a Current Report on Form 8-K dated January 11, 2016, the company had received a prior notification from NASDAQ, dated January 5, 2016, indicating that the company was not in compliance with the Rule because the minimum bid price of the company’s common stock on the NASDAQ Capital Market had closed below $1.00 per share for 30 consecutive business days. In the event the company does not regain compliance with the Rule by January 3, 2017, NASDAQ will notify the company that its common stock will be delisted from the NASDAQ Capital Market, unless the company requests a hearing before a NASDAQ Hearings Panel. This information is being provided solely to comply with NASDAQ Listing Rules requiring public announcement of the company’s receipt of the letter from NASDAQ.
Recent PR indicates response in December to do RS if not compliant approaching January 3, 2017.
Nice offload$$ Thanks IMNP
Reload when the price works back down.
Off load sounds more reasonable considering the climate
Perhaps it is one of those DIP buys we hear about from time to time to consider. LOL
Choppy sounds about right.
There should be some more positive PR'S coming out soon.
NASDAQ Grants Extension To Immune Pharmaceuticals Inc. To Regain Compliance With Requirements Under NASDAQ Listing Rule 5810(c)(3)
Jul 6 16
On July 6, 2016, Immune Pharmaceuticals Inc. received a notification from the Listing Qualifications Department of The NASDAQ Stock Market LLC (NASDAQ) indicating that the company had been granted an additional 180 calendar day extension, or until January 3, 2017, to regain compliance with the requirements under NASDAQ Listing Rule 5810(c)(3). The notification stated that Extension determination was based on the company meeting the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on the Capital Market, with the exception of the bid price requirement. The notification has no immediate effect on the NASDAQ listing or trading of the company’s common stock. As previously reported on a Current Report on Form 8-K dated January 11, 2016, the company had received a prior notification from NASDAQ, dated January 5, 2016, indicating that the company was not in compliance with the Rule because the minimum bid price of the company’s common stock on the NASDAQ Capital Market had closed below $1.00 per share for 30 consecutive business days. In the event the company does not regain compliance with the Rule by January 3, 2017, NASDAQ will notify the company that its common stock will be delisted from the NASDAQ Capital Market, unless the company requests a hearing before a NASDAQ Hearings Panel. This information is being provided solely to comply with NASDAQ Listing Rules requiring public announcement of the company’s receipt of the letter from NASDAQ.
chees We have until April 10,2017 I believe.
I appreciate your thoughts so eloquently expressed for all here
who wish to absorb.
Better numbers in Stockholm
IMNP:SS FN STOCKHOLM 2.12SEK
Donald Trump wants to know " What the hell is going on"?
The LONG,LONGS are taking a beating here and need to be rewarded for their loyalty at some point.
Realist perhaps you can enlighten us a bit you seem to have all the answers. What will it take to get the ship to sea?
Even Wook is stumped.
Just my 2 cents
Thanks for info sunstar
The ask price is the lowest price a seller of a stock is willing to accept for a share of that given stock. So let's see.
Perhaps SK can parcel out some of his salary to the long,long investors here as a consolation prize for being so loyal.
Sorry in sarcastic mood. GLTA
Disclosure not an investor in PP anymore but still trade it on the swing. Guess that makes me a temporary holder of shares.
Again sorry for the sarcasm.
Better days ahead but not now.
Agreed this is unfortunate.
Just about down to late May's dip. Guess your buying there to.
Thanks for sharing eb0783
Shorty owns volume. That's why
9/30/2016 4,295,295 3,654,341 1.175395
9/15/2016 2,972,192 3,758,535 1.000000
8/31/2016 2,013,511 2,642,330 1.000000
8/15/2016 951,173 3,343,282 1.000000
7/29/2016 757,968 1,397,340 1.000000
Read more: http://www.nasdaq.com/symbol/imnp/short-interest#ixzz4N03i6cMC
Ad HOC blood analysis was the MOA designed to determine effective treatment regimes for those that meet the criteria of the bio-markers. This procedure was certainly embedded in the Sunrise trial as mentioned in the PR and stated below. Let's see if anymore bio-markers emerge.
Treatments could be more effective in other indications.
The FDA certainly knew before hand what Peregrines intentions were and the FDA is on a new path to shorten trials, reduce patients in trials as much as possible, increase safety and efficacy and it looks like the FDA has a perfect opportunity here to do all that with PS Targeting biomarkers that allows a blood test to check for a biomarker that would help 30% of all lung cancer patients, just for starters till betabodies comes online and sounds like CP will be correct .