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.
ex, is this source of your misinformation?
NW Bio Announces Settlement with Cognate BioServices Resolving Past Matters and Providing for Restart of DCVax®-Direct Production
28 May, 2019
https://nwbio.com/nw-bio-announces-settlement-with-cognate-bioservices-resolving-past-matters-and-providing-for-restart-of-dcvax-direct-production/
In connection with the overall settlement, all past obligations of both Cognate and NW Bio were settled and all claims of both Cognate and NW Bio were released.
Linda Powers, CEO of NW Bio, observed, “We are happy to have resolved the past contractual issues and reached agreement on terms for a new manufacturing relationship with Cognate, putting us both in a position to move forward with a clean slate. We believe this is good for NW Bio and Cognate, good for our patients, and good for our shareholders. We greatly appreciate Cognate’s belief in NW Bio and its DCVax technology, and we look forward to a strengthened and reinvigorated partnership with Cognate as we move forward on our exciting programs.”
Or is this the source?
From the latest 10-Q November 12, 2019 https://sec.report/Document/0001104659-19-062726/
(6) We have possible contingent obligations to pay certain fees to Cognate BioServices (in addition to any other remedies) if we shut down or suspend its DCVax-L program or DCVax-Direct program. These obligations are not reflected in the accompanying balance sheets.
For a shut down or suspension of the DCVax-Direct program,at Cognate the Company must give 3 months’ advance notice.
For a shut down or suspension of the DCVax-L program at Cognate, the fees will be as follows:
· Prior to the last dose of the last patient enrolled in the Phase III trial for DCVax®-L or After the last dose of the last patient enrolled in the Phase III clinical trial for DCVax®-L but before any submission for product approval in any jurisdiction or after the submission of any application for market authorization but prior to receiving a marketing authorization approval: in any of these cases, the fee shall be $3 million.
· At any time after receiving product approval for DCVax®-L in any jurisdiction, the fee shall be $5 million.
For a shut down or suspension of the DCVax-L program at Advent, the Company must give 12 months’ advance notice.
As of September 30, 2019, no shut-down or suspension fees were triggered.
While our DCVax programs are ongoing, under our agreements with Cognate we are required to pay certain fees for dedicated production suites or capacity reserved exclusively for DCVax production, and pay for a certain minimum number of patients, whether or not we fully utilize the dedicated capacity and number of patients. The same is the case under our agreement with Advent. As previously reported, we recently settled certain disputed amounts that had been invoiced to us by Cognate.
ex, I thought Cognate has a contract to provide commercial manufacturing for DCVax-L. What changed? Or did you just want me to find it for you?
DCVAX®-L MANUFACTURING AND SERVICES AGREEMENT
This Amended and Restated Services Agreement (this “Agreement”), originally dated April 1, 2011 is entered into, effective as of January 17, 2014 (the “Effective Date”), by and between Cognate BioServices, a Delaware corporation (Cognate”), and Northwest Biotherapeutics, a Delaware corporation (“NW Bio”).
6.1 Term
This Agreement will remain in force until the later of seven (7) years from the Effective Date (the “Term”) or five (5) years after the first commercial sales of DCVax®-L Products pursuant to a Biologics License Application or marketing authorization (not a compassionate use, hospital exemption or similar authorization), unless terminated earlier pursuant to Section 6.2.
https://www.sec.gov/Archives/edgar/data/1072379/000114420414031414/v377229_ex10-40.htm
FDA Approves 5 New Costly Drugs Well Ahead of PDUFA Dates
Posted 26 November 2019 | By Zachary Brennan
https://www.raps.org/news-and-articles/news-articles/2019/11/fda-approves-5-new-costly-drugs-well-ahead-of-acti
Since 21 October, the US Food and Drug Administration (FDA) has been on a tear in approving five new drugs (all with list prices of more than $100,000 per year) months ahead of when they were expected to be approved.
For instance, FDA signed off on Vertex Pharmaceuticals’ Trikafta (elexacaftor/ivacaftor/tezacaftor), a new treatment for those with the most common cystic fibrosis mutation, after only three months of review and well ahead of its 19 March 2020 user fee action date.
On 14 November, more than three months ahead of its 27 February 2020 action date, FDA granted accelerated approval to BeiGene’s Brukinsa (zanubrutinib) for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.
One day later, Novartis’ Adakveo (crizanlizumab-tmca) won approval for its sickle cell disease treatment two months ahead of its PDUFA date in mid-January 2020. And yesterday, FDA granted an accelerated approval to another sickle cell drug, Global Blood Therapeutics’ Oxbryta (voxelotor), three months ahead of its PDUFA date.
Alnylam Pharmaceuticals’ Givlaari (givosiran), meanwhile, had a PDUFA date of 4 February 2020, but won approval on 20 November. But other recent approvals, like SK Life Sciences’ Xcopri (cenobamate tablets) to treat partial-onset seizures in adults, and Shionogi’s complicated urinary tract infection drug Fetroja (cefiderocol), won approvals near their PDUFA dates.
The string of quick approvals may provide more ammunition for those who criticize the agency for moving too quickly. An article in JAMA Internal Medicine last summer found that few cancer drugs approved via the accelerated approval pathway improved survival in confirmatory trials.
However, viewers of the recent Senate committee hearing considering a new FDA commissioner have seen there are still senators who believe FDA is not moving quickly enough with some approvals.
As the proportion of new drugs receiving expedited approvals in recent years has been increasing, so has the number of approvals for rare diseases.
Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, explained recently that the agency is working on its own analyses to provide “a more robust response” to these critiques of its approval standards.
She also explained how the high number of approvals in recent years for rare diseases may be influencing this perception of a lower bar, especially as more treatments are approved on the basis of a single-arm study or with an external control group. In addition, she pointed to the “astoundingly” high launch prices for some of these rare disease treatments that may also be part of the reason for the pushback.
Indeed, before discounts, Trikafta will cost $311,503 annually, Brukinsa will cost $12,935 for a 30-day supply, Adakveo will cost between $7,000 and $9,500 per month ($84,000 to $114,000 per year), Oxbryta will cost $125,000 per year and Givlaari will cost $575,000 per year.
FDA issues speedy approval of innovative sickle cell drug
By Meredith Wadman Nov. 26, 2019
https://www.sciencemag.org/news/2019/11/update-fda-issues-speedy-approval-innovative-sickle-cell-drug
The U.S. Food and Drug Administration (FDA) approved the sickle cell disease medication Voxelotor for market on 25 November, fully 3 months ahead of a statutory deadline for agency action. “Today’s approval provides additional hope to the 100,000 people in the U.S., and the more than 20 million globally, who live with this debilitating blood disorder,” acting FDA Commissioner Brett P. Giroir said in a statement.
FDA hastily approves Daiichi Sankyo/AZ’s cancer drug, weeks after US filing
December 23, 2019
https://pharmaphorum.com/news/fda-hastily-approves-daiichi-sankyo-azs-cancer-drug/
The FDA has approved an advanced breast cancer drug from AstraZeneca and Daiichi Sankyo in super-quick time.
The regulator has okayed the trastuzumab deruxtecan a few weeks after receiving a file making the case for it in metastatic HER2-positive disease in patients who have received two or more anti-HER2 based regimens. Branded as Enhertu (fam-trastuzumab-deruxtecaen-nxki), the drug consists of the antibody used in Roche’s Herceptin, linked to a topoisomerase inhibitor that is toxic to cancer cells. It therefore works by latching on to the cancer cells and delivering a payload to kill them, while ignoring healthy cells, and is designed for patients who have failed to respond to Roche’s HER2-targeting cancer drugs Herceptin, Perjeta, and Kadcyla.
The speed of approval shows just how keen the FDA is to new and effective cancer drugs – Daiichi only filed it in October. Faster Priority Reviews allow for approval within six months, but the FDA’s super-fast decision paves the way for a launch in the coming weeks. This has also been one of the fastest developments of a biologic drug, as Daiichi only began clinical trials four years ago.
AstraZeneca earlier this year asked investors for an extra $3.5 billion to finance a development and collaboration deal with Daiichi over the drug, paying $1.35 billion up front and up to $5.55 billion upon achievement of regulatory and other milestones. Under the agreement the two companies will split the development and marketing costs as well as global profits, except for Japan, where Daiichi will retain exclusive rights.
As the price paid suggests, Enhertu is tipped to become a blockbuster, with peak sales predicted to exceed $4.5 billion annually. FDA approval is based on the results of the single-arm, pivotal phase 2 DESTINY-Breast01 trial of Enhertu (5.4 mg/kg) monotherapy in 184 female patients with HER2 positive metastatic breast cancer.
Trial results showed a confirmed objective response rate of 60.3%, including a 4.3% complete response rate and a 56.0% partial response rate.
A median duration of response of 14.8 months was demonstrated as of August 1, 2019. In addition, a median progression free survival of 16.4 months based on a median follow-up of 11.1 months, was recently reported at the San Antonio Breast Cancer Symposium and published online in The New England Journal of Medicine. Enhertu does have a boxed warning for interstitial lung disease pneumonitis (ILD) and embryo-foetal toxicity.
Safety of Enhertu has been tested in a pooled analysis of 234 patients with unresectable or metastatic HER2 positive breast cancer, based on data from DESTINY-Breast01 and a phase 1 trial. ILD occurred in 9% of patients, and deaths due to ILD and/or pneumonitis occurred in six patients – two deaths have already been reported from the phase 1 trial and four deaths in the phase 2 DESTINY-Breast01 trial.
H2R, no, they weren’t required to hire a CFO due to the settlement, but the way I see it, Northwest Bio is a clinical stage company that is preparing to become a commercial stage company. A clinical stage company can be run with a handful of people, and do without a CFO, but a multi-billion-dollar biotech company can not. Linda and Les are hiring key personnel, and building out their management team now, to get them up to speed, and will delegate more and more going forward. The company is burning about $1M a month, so $20K for a CFO salary is not going to crush them, and she will be doing far more than just working with her former co-workers at BDO to remediate the financial weakness, so it is likely money well spent. (especially if it gets the SEC off their back, and gives Linda a little piece of mind, and the time to attend to more important matters)
I posted it previously, but here’s the SEC settlement: https://www.sec.gov/litigation/admin/2019/34-87281.pdf
Hi H2R, I’ve thought about that as well, and agree with you in part, but don’t necessarily think it signaled that the SAP process was complete. (although it could be) In the back of my mind has been the thought that the last time Northwest Bio needed regulatory approval from the four regulators for their trial enhancements in 2014, the process of submissions and reviews took 9 months, so I’m prepared for that possibility. (not that I think it will take that long) All of the hires last year point to preparation for the next stage of growth. As the company moves towards that, Linda and Les have less time to do many of the tasks they’ve previously done, so there’s more of a need now than in years past.
I think the timing of the CFO hire may have had more to do with the SEC settlement in October, and a desire to get their financial house in order going forward, and put the SEC investigation in the rear view mirror. The need for a full-time CFO, who will ensure SOX compliance became pressing. Within 60 days of the settlement, (October 10th) Northwest Bio was required to hire a consultant who hasn’t provided services or had affiliations with the company for the two prior years, to review NW Bio’s ICFR and provide recommendations for remediation, so they were no longer able to consult with Jean Davis. It seems that Linda was impressed with Ms. Davis’s SOX expertise and financial knowledge, multiple certifications, and felt comfortable working with her over the past couple of years, and was confident Ms. Davis would fill the need at CFO.
Déjà vu. We saw this same game a year ago.
There were 10 new highs in 2019 and I’d be willing to bet there will be many more than that in 2020!
11/12 $4
11/13 $4.20
11/15 $4.22
11/18 $4.33
11/19 $4.535
11/20 $4.735
11/21 $4.80
11/22 $4.99
11/25 $5.06
12/03 $5.13
whosleft, allegations remain merely assertions, until they can be proven.
And yes, he did recommend selling a stock (wind something therapeutics - a big loser) . . for tax-loss harvesting. : )
GGB, you'e right that the SEC investigation was resolved for peanuts and it amounted to a slap on the wrist for relatively minor infractions. (it makes one wonder what took so long) Management is certainly not the criminals that some here portray them to be, but they are not without fault either.
I doubt that the SEC spent millions on the investigation, maybe closer to the amount of the fine. And it’s not true that NW Bio was clean, the SEC found absolutely nothing, or that the disclosed material weakness were corrected in 2015 or 2016, which tells me that you haven’t actually read the settlement. I understand that some elements of SOX laws are difficult for small businesses like NW Bio to comply with, but it is a public company, and investors depend upon accurate and timely reporting of financial information, and should expect a public company to ensure that internal controls are in place to protect against any potential fraudulent financial reporting, despite their limited finances. Any potential partner would certainly expect no less.
The frivolous lawsuits were dismissed, but the SEC investigation did find (and NW Bio admitted) “material weakness relating to numerous areas of importance, including the review, supervision and monitoring of accounting operations throughout the organization.” (for 12 years!)
In the Matter of NORTHWEST BIOTHERAPEUTICS, INC. Respondent.
ORDER INSTITUTING CEASE-AND- DESIST PROCEEDINGS
https://www.sec.gov/litigation/admin/2019/34-87281.pdf
And as a side note: this settlement seems to be part of the reason behind the hire of Ms. Davis, since she was no longer able to consult with the company.
Respondent has undertaken to:
11. Retain, at its own expense, a qualified independent consultant (the “Consultant”) not unacceptable to the Commission staff, to review and evaluate Respondent’s ICFR and to provide recommendations for improvements as may be needed to complete its remediation plan and ensure compliance with ICFR requirements. This review and evaluation shall include an assessment of Respondent’s policies and procedures involving the approval and recording of current and historic transactions with related parties, policies and procedures regarding public disclosures, and corporate governance matters.
12. The Consultant should not have provided legal, auditing, or other services to, or have had any affiliations with, the Respondent, or any related party, during the two years prior to the issuance of this Order.
“First they ignore you. Then they ridicule you. And then they attack you and want to burn you. And then they build monuments to you.”
- Nicholas Klein
seems prescient . . .
iwasadiver, there was no mention of “median PFS” in the question or my answer.
The way I read the question: Is it possible for a patient, who wasn’t treated with DCVax-L, to live more than 11 months after surgery without the tumor returning? IF so, how?
I think it's possible that there is a very small percentage of survivors from the placebo arm who didn’t progress in that time, and it would very likely be due to methylated MGMT gene status, or possibly a combination of those prognostic factors.
Yes ae kusterer, there are at least 3 prognostic factors that could explain it: age <50 years, methylated MGMT gene status, and full surgical removal of the tumor.
Wishing Everyone a Healthy Joyous and Prosperous NewYear!
Thanks ex
Thanks biosectinvestor
Barcode I appreciate what you do and your depth of knowledge. Some of these patents are well after he left NW Bio. I’m not sure what to make of it.
https://patents.justia.com/inventor/benjamin-tjoa
Ha ha TopleRoad, that’s a good oneI If anyone thought the SAP was a ginormous task, it’s NOTHING compared to a BLA filing. IF Northwest Bio isn’t bought out or agrees to a partnership, they will have to hire consultants and contract that out, as it is WAY beyond their competence. It takes a dedicated and experienced team 3-6 months or more to file a BLA, but preparations (that Northwest is doing now) usually begin 12-18 months before. I wouldn’t even want to imagine how long it would take Northwest. . . .
Guidance for Industry
Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER)
https://www.fda.gov/media/77755/download
FDA’s Pre-Approval Inspection (PAI) Program and How to prepare for a successful outcome
https://www.fda.gov/media/94064/download
May 2, 2020
Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.
On May 2, 2018, the Company filed a Certificate of Amendment of its Seventh Amended and Restated Certificate of Incorporation (the “Certificate of Amendment”) with the Secretary of the State of Delaware, which effected an increase in the Company’s authorized shares of common stock, from 450,000,000 to 1,200,000,000, par value $0.001 per share and an increase in the Company’s authorized shares of preferred stock from 40,000,000 to 100,000,000, par value $0.001 per share. The foregoing description is qualified in its entirety by reference to the full text of the Certificate of Amendment, which is included as Exhibit 3.1 to this Current Report on Form 8-K and is incorporated herein by reference.
https://sec.report/Document/0001144204-18-024749/
Thanks for the post Idunno. May I make a request that all posters not provide links to “Endpoints” or “Stat” unless the article is essential and can’t be found elsewhere. Both websites employ “writers” (John Carroll and Adam F) who have spread lies and false rumors about Northwest Bio’s trial. I would encourage a boycott, and do not want to send them any traffic. Thank you in advance.
The direct link to the new FDA guidance is here: https://www.fda.gov/media/133660/download
Lykiri, Nice find. Thank you!
BrightBoy, “As of December 31, 2018, we have over 190 issued patents and more than 65 pending patent applications worldwide, grouped into 12 patent families. Of these, 181 issued patents and 35 pending patent applications directly relate to our DCVax products. In the United States and Europe, some of our patents and applications relate to the composition and use of products, while other patents and applications relate to other aspects such as manufacturing and quality control. For example, in the United States, we have four issued and seven pending patent applications that relate to the composition and/or use of our DCVax products. We also have other U.S patents and applications that cover, among other things, quality control for DCVax and an automated system which we believe will help enable the scale-up of production for large numbers of patients on a cost-effective basis. Similarly, in Europe, we have five patents issued by and six pending patent applications with the European Patent Office (“EPO”) that cover our DCVax products, and other patents and applications that cover aspects such as manufacturing and quality control, and the automated system. In Japan, we have seven issued patents and three pending patent applications relating to our DCVax products, as well as manufacturing related patents. Patents have been granted and are pending in other foreign jurisdictions which may be potential future markets for our DCVax products.
During 2018, two new patents were issued to us as part of our worldwide patent portfolio. The newly issued patents cover methods and devices for manufacturing dendritic cells related to our DCVax products, as well as encompassing certain dendritic cell compositions for direct injection into patient tumors related to DCVax-Direct.
During 2017, six new patents were issued to us as part of our worldwide patent portfolio. The newly issued patents cover a variety of subject matter, including certain processes and methods for manufacturing and for enhancing the potency of dendritic cells related to our DCVax products, as well as encompassing certain dendritic cell compositions for direct injection into patient tumors related to DCVax-Direct.
The expiration dates of the issued U.S. patents involved in our current business range from 2022 to 2026. The expiration dates of the issued European patents involved in our current business range from 2022 to 2024. For some of the earlier dates, we plan to seek extensions of the patent life, and believe we have reasonable grounds for doing so.”
https://www.sec.gov/Archives/edgar/data/1072379/000114420419017803/tv517288_10k.htm
gopgrip, What happened at ASCO has been mischaracterized by several recent posts in my opinion, so it’s important to remember what was going on at the time of ASCO 2018 for a little context. The Right to Try Legislative process was in the news for months leading up to ASCO 2018, and on May 30, 2018, (the day after ASCO started) President Trump signed S.204, the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act. Although 41 states had already passed Right to Try laws, the signing of S.204 made Right to Try the law of the land, creating a uniform system for terminal patients seeking access to investigational treatments, and it opened new pathways for terminally ill patients who had exhausted their government-approved options, and who couldn’t get into a clinical trial, access to treatments. History has since proved otherwise, but that was what was believed at the time.
So Linda Powers brought to ASCO four cancer patients and a family member of a cancer patient to who were not allowed into the clinical trial, but who still received DCVax, to give testimonials about their very emotional near-death experiences with cancer, and who received a new lease on life thanks to DCVax. And after they all spoke, Dr. Ashkan, a lead investigator in the clinical trial ended his remarks as follows:
Dr. Keyoumars Ashkan
“We also have to work with the regulatory bodies, and we probably ought to do that now, right, not even waiting, because we want this to be available to all the patients. Again, while it’s very nice about these studies… yes, those patients who are in better prognostic groups are going to benefit more… but there is a benefit to all patients. We want this available to absolutely everybody. And absolutely everybody cannot afford everything. So the cost needs to be brought right down, and again, I’m going to be fighting for that, because I want this available to all my patients. We need to get the prices down, work with the regulatory bodies, approve it at a price which patients can afford. And I think that’s incredibly important. And you know what? I think you have to do all that… why? Because we owe it to these guys [points to the patients on the stage]. Thanks very much.”
And then Linda Powers closed the presentation with this:
Linda Powers
??“Well that concludes our program for today. I wanted to say, on behalf of the whole Northwest Bio team that we’re really, really grateful to all our patients. Our patients are our best ambassadors, our best advocates. They tend to be really passionate, and very helpful in telling fellow patients about the treatment and we’re really grateful that they were all able to share their stories with us. We’re also grateful the investigators in the trial, a number of who are here with us, including the principal investigator Linda Liau who could not be with us today. Keymour is the lead investigator in Europe. We were really blessed to have 69 co-authors on that publication last week. That’s pretty unheard of. And we even had a couple who said afterwards, Hey I wanted to be on it” so 69 co-authors among our investigators, meaning, just as Keymour said, their own personal experience with their own patients – it’s the picture that Marnix described for you.
I want to just reiterate what I said at the beginning. As a company, we fully endorse, and it is our goal, for this technology to be widely available to patients. We don’t want this to be a treatment of last resort. We want this to be a frontline treatment. We’ve worked long and hard to make it practical. There’s only one manufacturing process per patient. We manufacture the whole set of doses for multi-year treatment in one batch. Then we freeze those doses, and we’ve validated the frozen shelf-life for years. So then it’s just an off-the-shelf product out of the freezer, although it’s fully personalized for that patient. So we’ve worked for years and years to try and make this a very practical product to be widely available.
Right now, it’s made by hand. That is a very obviously, expensive process. It’s the same thing that the T cell people are dealing with. And there will be steps in the future, whether it’s economies of scale, whether it’s closing the system and having to have clean rooms with people in space suits making this by hand, which is what it is today, or full end-to-end automation. So there’s a lot of steps to be done in the future. I would say to anyone who can help us, help us provide funding, provide technical support, help spread the word, help us. We want to get this to everyone. Thank you.”
So it was hardly a “meltdown” as BSB called it, and in my opinion, it was not unprofessional or inappropriate either. Perhaps it was an emotional plea and showed vulnerability, but it was sincere and heartfelt, and it’s obvious she cares deeply about helping cancer patients. I personally appreciate that.
Cancer Drug Company Acquisitions Showcase Pharma Giants Big Push Into Oncology
Sorry if this has been posted already. Article edited. Full article here:
https://fortune.com/2019/12/09/cancer-drug-company-acquisitions-oncology/
By Riley Griffin, James Paton, and Bloomberg December 9, 2019
Two of the world’s biggest pharmaceutical companies agreed to pay substantial premiums to acquire smaller cancer-drug makers, underlining the eagerness of the drug giants to add promising treatments to their oncology pipelines.
In separate deals announced Monday, Merck & Co. agreed to buy ArQule Inc., which is developing drugs known as kinase inhibitors, for $2.7 billion, while French drug giant Sanofi agreed to buy Synthorx Inc., a maker of therapies that harness the immune system to fight tumors, for $2.5 billion.
Both proposed transactions come with hefty price tags. In the ArQule deal, Merck will make a tender offer of $20 a share, more than double the smaller company’s closing price Friday. And in its deal for Synthorx, Sanofi agreed to pay nearly three times its target’s market value. . .
The substantial prices show that pharmaceutical giants are feeling increasingly pressed to pay up for companies that can restock their inventory of new drugs. For some time, drugmakers had balked at the lofty valuations of some publicly traded biotechnology companies.
Merck Chief Marketing Officer Michael Nally, who is seen as a potential candidate to replace Chief Executive Officer Kenneth Frazier, said at a conference last week that the company doesn’t have an appetite for mega-deals, but would likely focus on transactions under $10 billion.
Despite increasingly high premiums, “we’re not driven by the price of a deal,” Nally said. “We’re trying to find those spots where there’s those value-creating opportunities, and we look at everything. We’re not confined to a therapeutic area. We’re not confined to a size.”
A persistent rally in biotech stocks could be forcing drugmakers to get off the sidelines before prices for appealing takeover targets climb even higher. The Nasdaq Biotechnology Index has surged some 24% this year.
Deals like those unveiled Monday are likely to spur more gains in the sector, which is highly sensitive to takeover trends. . .
Merck already markets one of the world’s biggest-selling cancer treatments, the immunotherapy Keytruda, but like other large pharmaceutical companies, it has been searching for ways to expand its oncology offerings. Keytruda, which had 2018 sales of more than $7 billion, is expected to face increased competition in coming years.
“We’ve been very committed to using Keytruda as our cornerstone—a foundational component to many therapies—while adding on additional targets,” Roy Baynes, senior vice president and head of global clinical development for Merck Research Laboratories, said in an interview. “As we diversify our oncology platform, I think we’ll follow the science more than targeting specific areas of disease.”
ArQule, based in Woburn, Mass., is focused on kinase inhibitor discovery. Its lead drug candidate, ARQ-531, is currently being studied in patients with a range of blood cancers. The drug will compete with a promising asset Eli Lilly & Co. acquired through its $8 billion purchase of Loxo Oncology in January, which jump-started a year of deals for new cancer compounds.
“We were intrigued by the work that ArQule and others have been doing in this competitive space,” Baynes said. “The science has come to a moment in time where it looks very compelling. That was the driver moving ahead. Though the company has a number of other assets and a productive discovery engine, ARQ-531 is front and center.”
In the past, Merck executives had signaled that high prices for biotech companies had been an impediment to getting deals done. But recently, the company has been more open to doing deals, and willing to pay more. Earlier this year, it spent $5.1 billion to buy the cancer-drug maker Peloton Therapeutics a day before the company was set to debut on the stock market.
“We continue to think there is much more consolidation on the horizon” given the needs of drugmakers to beef up their pipelines, said Jared Holz, a health-care equity strategist at Jefferies LLC, in a note to clients.
BofA Securities acted as financial adviser to Merck on the deal, and Covington & Burling was its legal counsel. Centerview Partners was financial adviser and Skadden, Arps, Slate, Meagher & Flom was legal adviser to ArQule. . .
Kite Pharma timeline from topline announcement to FDA approval (and buyout) as a reference for a possible best-case timeline for Northwest Bio (13 months topline to approval / 11 months topline to buyout):
Kite Pharma Announces Positive Topline KTE-C19 Data from ZUMA-1 Pivotal Trial in Patients with Aggressive Non-Hodgkin Lymphoma (NHL)
Study Met Primary Endpoint of Objective Response Rate
September 26, 2016 (Press Release) - SANTA MONICA, Calif.--Kite Pharma, Inc., (Nasdaq:KITE) today announced positive topline results from a pre-planned interim analysis of ZUMA-1 for its lead product candidate, KTE-C19, in patients with chemorefractory diffuse large B-cell lymphoma (DLBCL). KTE-C19 met the primary endpoint of objective response rate (ORR)
Kite Pharma Initiates Rolling Submission of BLA for KTE-C19, its Investigational anti-CD19 CAR-T Therapy, for the Treatment of Patients with Relapsed/Refractory Aggressive B-cell Non-Hodgkin Lymphoma (NHL)
SANTA MONICA, Calif.--(BUSINESS WIRE) December 4, 2016 -- Kite Pharma, Inc. (Nasdaq:KITE) today announced that it has initiated the rolling submission with the U.S. Food and Drug Administration (FDA) of the Biologics License Application (BLA) for KTE-C19 as a treatment for patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant (ASCT). The pivotal ZUMA-1 study supporting this submission enrolled patients with chemorefractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL), three subtypes of aggressive NHL. The company expects to complete its BLA submission by the end of the first quarter of 2017.
"I am both proud and appreciative of the Kite team and our clinical investigators, who have helped to make this key milestone possible," said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer of Kite. "This is an important first step toward Kite's biggest goal - bringing to market a potentially life-saving treatment for patients suffering from aggressive NHL."
Kite also announced that the United States Adopted Name, or USAN, for KTE-C19 will be axicabtagene ciloleucel.
Axicabtagene ciloleucel (KTE-C19) received Breakthrough Therapy Designation (BTD) by the FDA in December 2015. If approved, Kite plans to commercially launch KTE-C19 in 2017. Kite is also planning a regulatory submission to the European Medicines Agency (EMA) for axicabtagene ciloleucel in 2017. Kite was granted access to Priority Medicines (PRIME) regulatory support in 2016 by the EMA for axicabtagene ciloleucel (KTE-C19) for the treatment of refractory DLBCL.
Kite Completes Submission of U.S. Biologics License Application (BLA) for Axicabtagene Ciloleucel as the First CAR-T Therapy for the Treatment of Patients With Aggressive Non-Hodgkin Lymphoma (NHL)
SANTA MONICA, Calif. March 31, 2017 --(BUSINESS WIRE)-- Kite Pharma, Inc. (Nasdaq:KITE) today announced that it has completed the rolling submission with the U.S. Food and Drug Administration (FDA) of the Biologics License Application (BLA) for axicabtagene ciloleucel (previously known as KTE-C19) as a treatment for patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant (ASCT)."Last month, we announced positive results from our ZUMA-1 pivotal trial with axicabtagene ciloleucel," said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer of Kite. "We look forward to working closely with the FDA during the review of axicabtagene ciloleucel and the possibility of bringing this therapy to patients with aggressive NHL whose outlook is dismal with current therapy."
In December 2015 axicabtagene ciloleucel received Breakthrough Therapy Designation (BTD) by the FDA for diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL). If approved, Kite plans to commercially launch axicabtagene ciloleucel in 2017. Kite is also planning a regulatory submission to the European Medicines Agency (EMA) for axicabtagene ciloleucel in 2017.
"The Leukemia & Lymphoma Society (LLS) applauds Kite for achieving this significant milestone and bringing this promising therapy closer to patients with lymphoma who desperately need new options," said Louis J. DeGennaro, Ph.D., LLS President and Chief Executive Officer. "LLS has supported companies that are working to dramatically change cancer treatment through the development of immunotherapy for the past two decades, and we immediately recognized the great opportunity to support Kite's CAR-T program in 2015 through our Therapy Acceleration Program ® (TAP). Partnerships created through TAP, now in its tenth year, have the potential to bring several breakthrough therapies, such as axicabtagene ciloleucel, to patients in the coming year."
The ZUMA-1 pivotal trial for axicabtagene ciloleucel for the treatment of patients with aggressive NHL was supported in part by funding from LLS' TAP.
Kite Receives U.S. Food and Drug Administration Priority Review for Axicabtagene Ciloleucel
SANTA MONICA, Calif.--(BUSINESS WIRE) May 26, 2017 -- Kite Pharma, Inc., (Nasdaq:KITE), a leading cell therapy company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for axicabtagene ciloleucel. The submission follows positive data demonstrated with a single infusion of axicabtagene ciloleucel in the ZUMA-1 Phase 2 trial in patients with refractory aggressive non-Hodgkin lymphoma (NHL). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 29, 2017.
"Patients with refractory aggressive NHL face a dire prognosis with only a 50 percent chance of surviving six months. This underscores the urgent medical need for these patients and why every day matters, from development to manufacturing to clinical experience," said David Chang, M.D., Ph.D., Executive Vice President of Research and Development and Chief Medical Officer of Kite. "We firmly believe in the potential for axicabtagene ciloleucel to address this need and forge a new path for the future of cell therapy."
The filing acceptance is supported by data from the ZUMA-1 Phase 2 trial which met the primary endpoint of objective response rate (ORR) recorded after a single infusion of axicabtagene ciloleucel with 82 percent (p < 0.0001). At a median follow-up of 8.7 months, 44 percent of patients were in ongoing response, which included 39 percent of patients in complete response (CR).
The most common grade 3 or higher adverse events included anemia (43 percent), neutropenia (39 percent), decreased neutrophil count (32 percent), febrile neutropenia (31 percent), decreased white blood cell count (29 percent), thrombocytopenia (24 percent), encephalopathy (21 percent) and decreased lymphocyte count (20 percent). There were three deaths throughout the course of the registrational trial not due to disease progression, of which two events, were deemed related to axicabtagene ciloleucel.
In December 2015, axicabtagene ciloleucel received Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for DLBCL, TFL, and PMBCL. The company expects to submit its Market Authorization Application (MAA) of axicabtagene ciloleucel with the European Medicines Agency (EMA) in the third quarter of 2017.
ZUMA-1 is supported in part by funding from The Leukemia & Lymphoma Society (LLS) Therapy Acceleration Program®.
Gilead Sciences to Acquire Kite Pharma for $11.9 Billion
August 28, 2017 07:00 AM Eastern Daylight Time
FOSTER CITY, Calif. & SANTA MONICA, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) and Kite Pharma, Inc. (Nasdaq: KITE) announced today that the companies have entered into a definitive agreement pursuant to which Gilead will acquire Kite for $180.00 per share in cash. The transaction, which values Kite at approximately $11.9 billion, was unanimously approved by both the Gilead and Kite Boards of Directors and is anticipated to close in the fourth quarter of 2017. The transaction will provide opportunities for diversification of revenues, and is expected to be neutral to earnings by year three and accretive thereafter.
FDA Approves Yescarta (axicabtagene ciloleucel) CAR-T Cell Therapy to Treat Adults with Certain Types of Large B-Cell Lymphoma
October 18, 2017 -- The U.S. Food and Drug Administration today approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta, a chimeric antigen receptor (CAR) T cell therapy, is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL).
“Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases. In just several decades, gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer,” said FDA Commissioner Scott Gottlieb, M.D. “This approval demonstrates the continued momentum of this promising new area of medicine and we’re committed to supporting and helping expedite the development of these products. We will soon release a comprehensive policy to address how we plan to support the development of cell-based regenerative medicine. That policy will also clarify how we will apply our expedited programs to breakthrough products that use CAR-T cells and other gene therapies. We remain committed to supporting the efficient development of safe and effective treatments that leverage these new scientific platforms.”
Diffuse large B-cell lymphoma (DLBCL) is the most common type of NHL in adults. NHLs are cancers that begin in certain cells of the immune system and can be either fast-growing (aggressive) or slow-growing. Approximately 72,000 new cases of NHL are diagnosed in the U.S. each year, and DLBCL represents approximately one in three newly diagnosed cases. Yescarta is approved for use in adult patients with large B-cell lymphoma after at least two other kinds of treatment failed, including DLBCL, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.
Each dose of Yescarta is a customized treatment created using a patient’s own immune system to help fight the lymphoma. The patient’s T-cells, a type of white blood cell, are collected and genetically modified to include a new gene that targets and kills the lymphoma cells. Once the cells are modified, they are infused back into the patient.
“The approval of Yescarta brings this innovative class of CAR-T cell therapies to an additional group of cancer patients with few other options – those adults with certain types of lymphoma that have not responded to previous treatments,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER).
mani (and anyone who thinks it’s a waste of money to attend industry conferences) read this Merger Prospectus when Gilead Sciences acquired Kite Pharma, and pay particular attention to the 2nd and 3rd paragraphs, and then you might better understand why it’s worth it for companies like Northwest Bio to attend all these industry conferences. And BTW - for anyone who wonders how merger discussions take place, read this . . .
Kite Pharma Merger Prospectus
https://www.sec.gov/Archives/edgar/data/882095/000104746917005534/a2233171zex-99_1a1a.htm
Background of the Offer and the Merger
The information set forth below regarding Kite was provided by Kite, and none of Parent, Purchaser or any of its affiliates or representatives takes any responsibility for the accuracy or completeness of any information regarding meetings or discussions in which Parent or its affiliates or representatives did not participate. The following contains a description of material contacts between representatives of Parent or Purchaser and representatives of Kite that resulted in the execution of the Merger Agreement and the agreements related to the Offer. For a review of Kite's activities relating to these contacts, please refer to Kite's Schedule 14D-9 that will be filed with the SEC and mailed to all Kite stockholders with this Offer to Purchase.
The board of directors of Parent (the "Parent Board") as well as Parent's executive management regularly evaluates various strategies to improve its competitive position and enhance value for Parent stockholders, including opportunities for acquisitions of other companies or their assets. Parent also meets with potential partners and acquisition targets on a regular basis to understand these companies' businesses and evaluate the potential opportunities.
26
As part of these regular evaluations, in January 2017, while attending an industry conference, Andrew Dickinson, Senior Vice President, Corporate Development of Parent and Helen Kim, Executive Vice President, Business Development of Kite met informally and generally discussed Parent's interest in the oncology field and potentially learning more about Kite. Representatives of Kite and Parent had in the preceding two years engaged in similar informal discussions, but these interactions ceased without any definitive proposals or agreements. Shortly after the conference, Mr. Dickinson followed up with Ms. Kim and they agreed to put in place a confidentiality agreement to facilitate this latest set of discussions. Parent and Kite thereafter entered into a confidentiality agreement to facilitate such further discussions, dated February 10, 2017, providing for the sharing of information with a purpose of discussing, evaluating, negotiating and potentially entering into a business transaction involving Kite and Parent.
Following the execution of the confidentiality agreement, certain menbers of senior management of Kite and Parent met in March, April and May of 2017. The topics discussed included updates on clinical studies of axicabtagene ciloleucel ("axi-cel"), manufacturing capabilities for axi-cel, contemplated activities in the U.S. and E.U. regarding axi-cel and preparation for commercialization, Kite's other pipeline programs, Kite's general thoughts on partnerships and Parent's oncology strategy.
After the three meetings between senior management teams of Parent and Kite, in late May of 2017, John F. Milligan, Ph.D., President, Chief Executive Officer and a director of Parent, contacted Dr. Arie Belldegrun, Kite's Chairman, President and Chief Executive Officer, to discuss the interactions that the management teams had been having and to request a meeting between the two executives.
On June 12, 2017, Dr. Belldegrun met with Dr. Milligan and Kevin Young, CBE, Chief Operating Officer of Parent and discussed the interactions of the management teams.
On June 29, 2017, Parent held an informal meeting with certain members of the Parent Board to provide a general update on corporate development discussions, including updates on the recent discussions with Kite.
On June 30, 2017, Dr. Milligan and Alessandro Riva, M.D., Senior Vice President, Oncology Therapeutics of Parent met with Dr. Belldegrun, Cynthia Butitta, Kite's Chief Operating Officer, Shawn Tomasello, Kite's Chief Commercial Officer and Tim Moore, Kite's Executive Vice President, Technical Operations. At this meeting the parties continued their discussions regarding the commercialization and manufacturing plans for axi-cel as well as how the companies might partner.
On July 7, 2017, Dr. Milligan and Dr. Belldegrun spoke regarding another potential in-person meeting in the coming weeks.
On July 10, 2017, Parent held an informal meeting with certain members of the Parent Board to discuss the potential commercial market for Kite's product pipeline and the unique sales and delivery model for CAR-T products. The Parent Board also discussed Parent's preliminary analysis of Kite's business and pipeline.
On July 12, 2017, Novartis AG announced that the U.S. Food and Drug Administration (the "FDA") Oncologic Drugs Advisory Committee ("ODAC") unanimously recommended approval of CTL019 (tisagenlecleucel), an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of relapsed or refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia. Parent closely monitored the ODAC meeting and its recommendation because tisagenlecleucel had the potential to be the first-ever CAR-T approved by the FDA. Although Kite's CAR-T therapy, axi-cel, was submitted for approval for a different indication, the outcome of the ODAC meeting was important to further inform Parent's evaluation of Kite and CAR-T therapies.
On July 13, 2017, Dr. David Chang, Kite's Executive Vice President, Research and Development and Chief Medical Officer met with Dr. Milligan, John C. Martin, Ph.D., Parent's Executive Chairman of the Board, John G. McHutchinson, M.D., Parent's Executive Vice President, Clinical Research, Dr. Riva and Taiyin Yang, Ph.D., Parent's Executive Vice President, Pharmaceutical Development and
27
Manufacturing at Parent's headquarters in Foster City, California and discussed the status of axi-cel and Kite's other pipeline products as well as Kite's research organization, manufacturing and supply logistics.
On the morning of July 14, 2017, Parent's Board met to receive an update on the discussions with Kite to date as well as an overview of Kite's manufacturing processes. The Parent Board and executive management also discussed Parent's preliminary valuation analysis on Kite. After discussion, the Parent Board authorized management to submit a non-binding acquisition proposal to Kite to acquire all of the assets of Kite at a price of $127 per Share in cash.
On July 16, 2017, Dr. Milligan and Mr. Young contacted Dr. Belldegrun to inform him that Parent planned to send a letter to Kite offering to acquire all of the assets of Kite at a price of $127 per Share in cash. Later that day, Parent submitted a letter to Kite expressing its interest in acquiring all of the assets of Kite at a price of $127 per Share, a 51% premium to Kite's 60-day volume weighted average stock price, in an all-cash tender offer (the "July 16 Proposal").
On July 19, 2017, Dr. Belldegrun spoke with Dr. Milligan and informed him that he had spoken with the board of directors of Kite (the "Kite Board") and they had determined that Kite was not for sale and that the July 16 Proposal was not sufficient to proceed with further discussions about a potential acquisition of Kite.
On July 20, 2017, at a meeting of the Parent Board, Dr. Milligan and Mr. Dickinson provided an update regarding the recent communications between Dr. Milligan and Dr. Belldegrun as well as an updated valuation analysis of Kite based on information learned in those discussions and further internal analyses. After significant discussion, the Parent Board authorized management to submit a revised proposal to Kite, with the offer price to be approved by the Parent Board.
Only July 24, 2017, Parent convened a meeting of the Parent Board to determine the offer price for Parent's revised acquisition proposal. After discussion, the Parent Board authorized Parent management to submit a revised acquisition proposal to acquire all of the assets of Kite for $160 per Share in cash and request exclusivity to proceed with negotiations and due diligence.
On July 25, 2017, Dr. Milligan contacted Dr. Belldegrun and they agreed to meet again on July 28th.
On July 28, 2017, Dr. Belldegrun met with Dr. Milligan and Dr. Martin. At this meeting, Dr. Belldegrun discussed Kite's product candidates, pipeline and prospects. At the end of the meeting, Dr. Milligan and Dr. Martin informed Dr. Belldegrun that Parent would be prepared to increase its offer to $160 per Share in cash. Although Dr. Belldegrun once again expressed disappointment with the offer price, he agreed to facilitate a meeting on August 1st with management of Parent and Kite to provide further perspectives on value in order to demonstrate to Parent why neither the management team nor the Kite Board would be interested in pursuing a transaction at this time at that price level.
Later that same day, Parent confirmed in a letter the increase of its offer to $160 per Share in cash (the "July 28 Proposal") for all of the assets of Kite, an 85% premium to Kite's 60-day volume weighted average stock price and a 26% increase from the July 16 Proposal. The letter indicated that Parent wanted to finish the discussions within weeks to minimize disruption of the pending launch of axi-cel and was prepared to immediately review due diligence materials.
Also on July 28, shortly after the meeting, Dr. Belldegrun proposed that executives from Kite and Parent meet in Los Angeles on August 1, 2017 to further discuss Kite's business and commercial operations and their internal financial projections.
On July 31, 2017, Parent held an informal meeting with certain members of the Parent Board to provide an update on Dr. Milligan's and Dr. Martin's discussions with Dr. Belldegrun the prior week and discuss the upcoming meeting in Los Angeles.
28
On August 1, 2017, Dr. Belldegrun, Ms. Butitta, Dr. Chang and Ms. Kim met with Dr. Milligan, Mr. Dickinson, Dr. Riva and Mr. Young to discuss Kite's financial model and assumptions supporting the model, clinical data for axi-cel for various indications, commercial launch plan and assumptions for axi-cel and product pipeline and next generation products from Kite's technology platform (the "August 1 Meeting"). At the end of this meeting, Dr. Milligan and Dr. Belldegrun met separately to discuss the July 28 Proposal. Dr. Belldegrun expressed his disappointment to Dr. Milligan at the level of the offer, making clear that the Kite Board had unanimously rejected the offer and that any future offer would need to be a compelling one. Dr. Milligan indicated to Dr. Belldegrun that he was going to find it very difficult to go back to the Parent Board and request an increased price.
On August 2, 2017, Dr. Milligan emailed Dr. Belldegrun to thank him for the meeting the day before and indicated that he would look forward to catching up with Dr. Belldegrun in the future.
On August 2, 2017, Parent held an informal meeting with certain members of the Parent Board to provide an update on the meeting between the companies the prior day.
Between August 2 and August 7, Parent reviewed the information Kite presented at the August 1 Meeting and its internal analyses to date.
On August 7, 2017, Dr. Milligan contacted Dr. Belldegrun and indicated that he would like to continue discussions between the parties. In this discussion, Dr. Milligan indicated that Parent's offer could potentially be increased, but Dr. Milligan did not present a revised offer at that time and indicated that any matters regarding price would need to be discussed with the Parent Board. Dr. Belldegrun agreed to arrange a meeting between Mr. Young, Dr. Riva and Mr. Dickinson from Parent and Dr. Chang, Ms. Buttita and Ms. Kim from Kite on Friday, August 11.
On the morning of August 8, 2017, Kite released its earnings for the second quarter of 2017 and held its earnings call with the investment community. During the call, among other positive news, Kite announced it had filed an IND for KITE-585 and that the FDA would not need an advisory committee to review Kite's new drug application for axi-cel.
On August 11, 2017, Ms. Butitta, Dr. Chang and Ms. Kim met with Mr. Dickinson, Dr. Riva and Mr. Young to discuss Parent's assumptions underlying its financial modeling for Kite, focusing primarily on market shares and pricing for the products (the "August 11 Meeting").
On August 14, 2017, Parent held a meeting of the Parent Board to provide an update on the recent discussions with Kite and updates to Parent's financial valuation of Kite. Dr. Milligan and Mr. Dickinson highlighted new information obtained in the August 1 Meeting and August 11 Meeting with Kite, data announced by competitors and Kite's public announcements over the past week that all factored into adjustments to Parent's financial model. Based on this information and the model updates, after significant discussion, the Parent Board authorized management to submit a non-binding acquisition proposal to acquire all of the assets of Kite at a price of up to $180 per Share in cash.
On August 16, 2017, Dr. Milligan and Dr. Belldegrun discussed next steps and agreed that they and Dr. Martin should meet in person in New York City on August 18, 2017.
On August 17, 2017, Parent held an informal meeting with certain members of the Parent Board to provide an update on Dr. Milligan and Dr. Belldegrun's discussion the prior day and to discuss strategy for the upcoming meeting between the companies in New York City.
On the evening of August 18, 2017, Dr. Belldegrun met with Dr. Milligan and Dr. Martin in New York. Dr. Milligan and Dr. Martin indicated that Parent was prepared to offer $176 in cash per Share to acquire all of the assets of Kite. Dr. Milligan and Dr. Martin expressed that Parent was prepared to move quickly and was interested in a transaction structured as a cash-tender offer followed by a second step merger and wanted to complete its diligence and negotiation of a merger agreement in the following ten days. Dr. Belldegrun indicated that he believed there was significant potential value in some of Kite's early stage pipeline and indicated that he believed that Parent should increase its offer to $180 per Share in cash. Dr. Milligan indicated that at $180 per Share in cash, he would be willing to
29
recommend that the Parent Board approve the acquisition of all of the assets of Kite. Dr. Milligan and Dr. Martin advised that they would submit a formal offer letter with the $180 per Share price together with a draft merger agreement later that night. Dr. Belldegrun indicated that he would be prepared to recommend that price to the Kite Board.
Later that evening, Parent confirmed in writing its updated offer of $180 per Share in cash (the "August 18 Proposal"), which represented a premium of 82% to Kite's 60-day volume weighted average stock price, an increase of 42% from the July 16 Proposal and an increase of 13% from the July 28 Proposal. The August 18 Proposal was for all of the assets of Kite and indicated that Parent expected the parties to move quickly to complete diligence and sign an acquisition agreement. Mr. Dickinson sent Dr. Belldegrun a draft of the merger agreement, and Parent's outside legal counsel, Skadden, Arps, Slate, Meagher & Flom LLP ("Skadden Arps"), provided Sullivan & Cromwell with a draft tender and support agreement to be delivered by each of the directors and officers of Kite in which they would agree to tender their Shares into the Offer.
On August 20, 2017, Dr. Belldegrun called Dr. Milligan and informed him that Kite had held a meeting of the Kite Board and, in light of the August 18 Proposal, the Kite Board was interested in continuing to provide disclosures and have discussions with Parent.
Also on August 20, 2017, Kite provided Parent access to a data room in order for Parent to perform its confirmatory due diligence investigation of Kite. Parent continued to perform due diligence through the execution of the Merger Agreement.
On August 22, 2017, Sullivan & Cromwell delivered comments on the draft Merger Agreement to Skadden Arps.
Over the next several days Kite, Parent, Sullivan & Cromwell and Skadden Arps discussed the terms of the Transactions, focusing on the elimination of the tender and support agreement, the size of the termination fee, the circumstances under which Kite could negotiate alternative proposals and accept superior offers, the representations and warranties, the interim operating restrictions and the provisions relating to employees.
On August 24, 2017, Parent held an informal meeting with certain members of the Parent Board to provide a recap of the recent meeting with Dr. Martin and Dr. Belldegrun in New York City and a status update on the due diligence review of Kite and merger agreement negotiations.
On August 24, 2017, Dr. Milligan and Dr. Belldegrun discussed a number of matters, including, in a conversation that also included Mr. Dickinson and Katie L. Watson, Parent's Executive Vice President, Human Resources, strategies with respect to retention of Kite employees after the closing of the potential Transactions.
On August 25, 2017, Parent held a meeting of the Parent Board to provide a further status update on the due diligence review of Kite and merger agreement negotiations. Later that day, Parent formally engaged Merrill Lynch, Pierce, Fenner & Smith Incorporated ("Merrill") and Lazard Freres & Co. LLC ("Lazard") to act as Parent's financial advisors with respect to the potential acquisition of Kite.
After this meeting, the parties discussed the requests of the Kite Board's transaction committee and shortly thereafter agreed upon substantially all of the terms of the Merger Agreement. During the course of the day and evening on August 26, 2017, Mr. Dickinson and Ms. Kim negotiated final points on the Merger Agreement. Representatives from Skadden Arps and Sullivan & Cromwell also continued to trade drafts and conduct negotiations on the merger agreement, the negotiations of which were completed overnight on August 26, 2017.
On August 27, 2017, at a meeting of the Parent Board, Parent management provided an update on the valuation of Kite based on completion of due diligence and a summary of the merger agreement. Parent's Board unanimously approved entering into the merger agreement with Kite. Dr. Milligan then called Dr. Belldegrun to inform him of Parent's Board approval. Kite then convened a meeting of the
30
Kite Board to review the final merger agreement and disclosure schedules and approve entering into the definitive merger agreement with Parent. After the meeting was concluded, Dr. Belldegrun called Dr. Milligan to inform him that the Kite Board had unanimously approved Kite entering into a definitive merger agreement with Parent.
Following the Kite Board meeting, Kite, Parent and Purchaser executed the Merger Agreement.
Before the opening of trading on the NASDAQ Stock Market on August 28, 2017, Parent and Kite issued a joint press release announcing the execution of the Merger Agreement and the forthcoming commencement of a tender offer by Parent to acquire all the outstanding Shares of Kite at a price of $180 per Share in cash.
On September 5, 2017, Purchaser commenced the Offer and filed this Schedule TO-T.
Agreed Umibe, it was unrealistic for me to think that Linda would hire and pay a CFO a salary package equal to, or above her own, which is what it would require, and I also think she would want to avoid any control issues that a CFO of that caliber might have. It’s pretty clear that Linda simply wanted to hire a CFO that was an expert in Sarbanes-Oxley matters, and one who would improve their controls and procedures to satisfy the SEC. Although Northwest Bio’s science is big league, I’m continually reminded that the company itself, is not.
Right mani, speculation and opinions on a message board. Imagine that. If it wasn’t for your 1700 posts, one might think you were new to this. And there you go again with factual inaccuracies. Do I have to prove you wrong again?
drugrunner, let me first reiterate that hiring a CFO is a very positive step, and is indicative of preparation in advance of the next phase of Northwest’s commercialization and growth stage, and I have been eagerly anticipating this news for some time. I would argue that the CFO is one of the most critically important positions for an organization, particularly one with a history of compliance issues. The CFO position for many larger companies has evolved from merely being responsible for keeping the books and records, financial reporting, and statutory compliance, to more of a strategic, operational and leadership role.
The ability to attract top-tier scientific talent like Dr. Duffy, who was willing to leave Merck for Northwest Bio was very encouraging, and I would have been ecstatic to see an experienced CFO from a Fortune 500 Company (much less a Fortune 100 Company like Merck) willing to move to Northwest. I believe that ones own expectations are at least partly responsible for the level of satisfaction that one receives, and I readily admit that my expectations for this hire were too high. I certainly didn’t intend to disparage Ms. Davis, by noting my personal reaction to her level of experience for this important position. I’m a shareholder in a number of small companies, and sometimes I forget about the quality or experience level of personnel that they are able to attract until I listen to the amateurish conference calls.
I agree Jack, hiring a CFO is a BIG DEAL and is one of the key indicators that I have been waiting for. I have to admit that I’m a little underwhelmed and had hoped for a more “seasoned” and well-known CFO, (and one who isn’t going to wear 3 hats) as well, but it’s definitely good to see.
Thanks pgsd. There is another:
Phacilitate Leaders World and Stem Cell Summit 2020
JANUARY 21-24, 2020
HYATT REGENCY, MIAMI
Northwest Biotherapeutics
Exhibitor
Northwest Biotherapeutics is developing personalized DCVax® dendritic cell-based immunotherapies for both operable and inoperable solid tumors. The Company is conducting a Phase III trial of DCVax-L for newly diagnosed Glioblastoma multiforme brain cancer in the US and Europe. The Company is also conducting a 60-patient Phase I/II trial with DCVax-Direct for all types of inoperable solid tumors.
Booth number
S52
?
https://www.phacilitate-leaders-world.com/sponsors--exhibitors/northwest-biotherapeutics
edwick, this is the conference where Dr. Bosch is speaking today https://glioblastoma-drugdevelopment.com/about/speakers/
but it is not being webcast. David Innes, (VP of Investor Relations at Northwest Bio) said Dr. Bosch's presentation slides will be made available on NW Bio's website after the conference. (https://nwbio.com )
Agreed Doc. And it probably comes as no surprise that ImmunoCellular’s assets were snapped up for a mere $1M, and we haven’t seen the last of them.
https://www.prnewswire.com/news-releases/immunocellular-therapeutics-announces-asset-purchase-agreement-with-private-biotechnology-company-300885579.html
mani, Cognate has publicly announced manufacturing agreements with Medeor Therapeutics and Caladrius Biosciences. In the time it took you to post that question, you could have done a quick search and found that information.
https://www.cognatebioservices.com/category/press-releases/
I’m THANKFUL for this board and want to take a moment to say THANK YOU to the many contributors who share their thoughts, knowledge, and information. It is very much appreciated.