Monopar files for patent for Covid-19 treatment

Monopar, NorthStar file provisional patent for development, use of RITs

Monopar Therapeutics (MNPR) and NorthStar Medical Radioisotopes announced that a provisional patent application entitled “Precision Radioimmunotherapeutic Targeting of the Urokinase Plasminogen Activator Receptor for Treatment of Severe COVID-19 Disease” has been filed with the U.S. Patent and Trademark Office.

The patent application offers hope for Covid-19 patients, Stockwinners

This application covers novel compositions and uses of cytotoxic radioisotopes attached to antibodies that bind to uPAR, thereby creating precision targeted radiotherapeutics for the treatment of severe COVID-19 and other respiratory diseases.

Advanced COVID-19 patients frequently develop severe, life-threatening, pulmonary inflammation as a result of a viral induced cytokine storm.

The development of this cytokine storm is associated with a high rate of mortality in severe COVID-19 patients, even with oxygen support and mechanical ventilation.

A severe immune reaction in which the body releases too many cytokines into the blood too quickly. Cytokines play an important role in normal immune responses, but having a large amount of them released in the body all at once can be harmful. A cytokine storm can occur as a result of an infection, autoimmune condition, or other disease. It may also occur after treatment with some types of immunotherapy.

Signs and symptoms include high fever, inflammation (redness and swelling), and severe fatigue and nausea. Sometimes, a cytokine storm may be severe or life threatening and lead to multiple organ failure. Also called hypercytokinemia.

uPRITs have been designed with the goal of selectively destroying the aberrantly activated white blood cells responsible for causing the cytokine storm.

If successful, healthy tissue would be spared in the process as the uPAR target is primarily only present on this unique class of white blood cells and not in healthy tissue.

The co-inventors of the provisional patent application are James Harvey, Chief Scientific Officer of NorthStar, and Andrew P. Mazar, Chief Scientific Officer of Monopar.

If granted, the patent would offer exclusivity to Monopar and NorthStar for the development and potential use of uPRITs in the treatment of severe COVID-19 and other respiratory diseases.

This provisional patent application leverages the therapeutic radioisotope expertise of NorthStar and the translational expertise of Monopar to create a novel, targeted radioimmunotherapeutic.

Radioimmunotherapy uses an antibody labeled with a radionuclide to deliver cytotoxic radiation to a target cell. In cancer therapy, an antibody with specificity for a tumor-associated antigen is used to deliver a lethal dose of radiation to the tumor cells.

On June 16, 2020, Monopar and NorthStar announced a 50/50 collaboration to couple Monopar’s MNPR-101 uPAR targeting monoclonal antibody to a therapeutic radioisotope provided by NorthStar.

MNPR closed at $6.91.

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Amarin shares tumble as court voids patent

Amarin ‘strongly disagrees’ with ruling in Vascepa ANDA litigation

Shares of Amarin (AMRN) tumbled in after hours trading after a federal judge ruled patents on its best selling drug, Vascepa was invalid. The company issued the following statement after shares tumbled 65 percent.

Amarin loses patent on its Vascepa, Stockwinners

Vascepa (Icosapent ethyl) is a type of omega-3 fatty acid, a fat found in fish oil. It is used along with a proper diet to help lower fats (triglycerides) in the blood. This medication is thought to work by decreasing the amount of triglycerides made by the body.

Amarin Corporation (AMRN) commented on the United States District Court for the District of Nevada’s ruling in favor of the generic companies in the company’s patent litigation against two filers of abbreviated new drug applications, or ANDAs, for Amarin’s VASCEPA capsule franchise.

Vascepa is derived from fish oil, Stockwinners

Based on Amarin’s review of U.S. Food and Drug Administration’s website, an ANDA for VASCEPA has not been approved, which would be required for launch of a generic product in the United States.

The company thus does not believe there is an impending generic launch by the litigants that would compete with VASCEPA at this time.

“Amarin strongly disagrees with the ruling and will vigorously pursue all available remedies, including an appeal of the Court’s decision and a preliminary injunction pending appeal to, if an ANDA is approved by FDA, prevent launch of generic versions of VASCEPA in the United States,” said John F. Thero, president and chief executive officer of Amarin.

“At Amarin, we have a strong balance sheet with capacity and flexibility, and we plan to fight to protect our VASCEPA franchise for the benefit of our patients, physicians, the broader healthcare community and our investors.

We believe we are favorably situated to obtain an injunction against generic launch pending appeal, subject to our posting a bond to secure generics’ lost profits in the event that generics prevail on appeal.

UK’s Hikma Pharma. had asked for overturn of the patent

As we work to take all legal actions necessary to defend and protect our intellectual property, we will continue to press forward with our educational and promotional efforts for VASCEPA in treating indicated patients at high risk of cardiovascular events, such as heart attack and stroke. After we determine the outcome of our effort to prevent a generic launch (if an ANDA approval is obtained), we expect to provide an update on how we would adjust certain promotional activities for VASCEPA in the United States.”

Generic drug maker Dr. Reddy’s will be making generic Vascepa

Generic drugmakers Hikma Pharmaceuticals of UK and Dr. Reddy’s Laboratories Limited  (RDY) had asked to overturn the patents so they can begin making generic versions of the medication.

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Central Banks flood markets with cash

  • Fed lowers federal funds target rate to 0%-0.25% on coronavirus outbreak
  • Fed, other central banks announce action to enhance U.S. dollar liquidity
  • Fed to up Treasury securities holdings by at least $500B, MBS by at least $200B
  • Expect added volatility in financial markets
Corona slowdown leads to drastic decisions, Stockwinners

The Federal Reserve said in a Sunday night statement, “The coronavirus outbreak has harmed communities and disrupted economic activity in many countries, including the United States. Global financial conditions have also been significantly affected.

Available economic data show that the U.S. economy came into this challenging period on a strong footing. Information received since the Federal Open Market Committee met in January indicates that the labor market remained strong through February and economic activity rose at a moderate rate. Job gains have been solid, on average, in recent months, and the unemployment rate has remained low. Although household spending rose at a moderate pace, business fixed investment and exports remained weak. More recently, the energy sector has come under stress.

Global inflation from 2007-2017, Stockwinners

On a 12-month basis, overall inflation and inflation for items other than food and energy are running below 2 percent.

Market-based measures of inflation compensation have declined; survey-based measures of longer-term inflation expectations are little changed. Consistent with its statutory mandate, the Committee seeks to foster maximum employment and price stability. The effects of the coronavirus will weigh on economic activity in the near term and pose risks to the economic outlook.

In light of these developments, the Committee decided to lower the target range for the federal funds rate to 0 to 1/4 percent.

The Committee expects to maintain this target range until it is confident that the economy has weathered recent events and is on track to achieve its maximum employment and price stability goals. This action will help support economic activity, strong labor market conditions, and inflation returning to the Committee’s symmetric 2 percent objective.”


The Federal Reserve said “To support the smooth functioning of markets for Treasury securities and agency mortgage-backed securities that are central to the flow of credit to households and businesses, over coming months the Committee will increase its holdings of Treasury securities by at least $500 billion and its holdings of agency mortgage-backed securities by at least $200 billion. The Committee will also reinvest all principal payments from the Federal Reserve’s holdings of agency debt and agency mortgage-backed securities in agency mortgage-backed securities.

QE 4 initiated by the Feds on a Sunday night, Stockwinners

In addition, the Open Market Desk has recently expanded its overnight and term repurchase agreement operations. The Committee will continue to closely monitor market conditions and is prepared to adjust its plans as appropriate,” the central bank announced.


In an extraordinary move, the Bank of Canada, the Bank of England, the Bank of Japan, the European Central Bank, the Federal Reserve, and the Swiss National Bank announced a coordinated action to enhance the provision of liquidity via the standing U.S. dollar liquidity swap line arrangements.

The Federal Reserve stated: “These central banks have agreed to lower the pricing on the standing U.S. dollar liquidity swap arrangements by 25 basis points, so that the new rate will be the U.S. dollar overnight index swap rate plus 25 basis points.

To increase the swap lines’ effectiveness in providing term liquidity, the foreign central banks with regular U.S. dollar liquidity operations have also agreed to begin offering U.S. dollars weekly in each jurisdiction with an 84-day maturity, in addition to the 1-week maturity operations currently offered. These changes will take effect with the next scheduled operations during the week of March 16.

The new pricing and maturity offerings will remain in place as long as appropriate to support the smooth functioning of U.S. dollar funding markets. The swap lines are available standing facilities and serve as an important liquidity backstop to ease strains in global funding markets, thereby helping to mitigate the effects of such strains on the supply of credit to households and businesses, both domestically and abroad.”

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AstraZeneca and Merck report prostate cancer data

AstraZeneca, Merck presents results from Phase 3 PROfound trial of LYNPARZA

AstraZeneca (AZN) and Merck (MRK) presented detailed results from the Phase 3 PROfound trial in 387 men with metastatic castration-resistant prostate cancer who have a mutation in their homologous recombination repair genes and whose disease had progressed on prior treatment with new hormonal agent treatments e.g. abiraterone or enzalutamide.

see Stockwinners.com
AstraZeneca and Merck report prostate cancer, Stockwinners

The trial was designed to analyze men with mCRPC harboring HRR-mutated genes in two cohorts: the primary endpoint was in those with mutations in BRCA1/2 or ATM genes and then, if LYNPARZA showed clinical benefit, a formal analysis was performed of the overall trial population of men with HRRm genes.

Merck presents results from Phase 3 KEYNOTE-426 study, Stockwinners
AstraZeneca and Merck report prostate cancer , Stockwinners

Results showed a statistically-significant and clinically-meaningful improvement with LYNPARZA in the primary endpoint of radiographic progression-free survival in BRCA1/2 or ATM-mutated tumors reducing the risk of disease progression or death by a median of 7.4 months versus 3.6 months for those receiving abiraterone or enzalutamide.

LYNPARZA reduced the risk of disease progression or death by 66% for these men. The trial also met the key secondary endpoint of rPFS in the overall HRRm population, where LYNPARZA reduced the risk of disease progression or death by 51% and improved rPFS to a median of 5.8 months vs. 3.5 months for those receiving abiraterone or enzalutamide.

In the key secondary endpoint of time to pain progression, median TTPP was not reached with LYNPARZA and was 9.92 months with abiraterone and enzalutamide in patients with BRCA1/2 or ATM mutations.

Results also showed a trend at this interim analysis time point for improvement in overall survival, another key secondary endpoint. LYNPARZA extended OS to a median of 18.5 months versus 15.1 months for abiraterone or enzalutamide in men with BRCA1/2 or ATM-mutated tumors, of which 81% started on abiraterone or enzalutamide and, following confirmed disease progression, then switched to LYNPARZA.

At this interim analysis, the OS endpoint did not meet statistical significance. In an exploratory analysis, a similar trend in OS was observed at this interim analysis in the HRRm population with a median of 17.5 months for men treated with LYNPARZA vs. 14.3 months for those receiving abiraterone or enzalutamide.

The trial showed a confirmed overall response rate a key secondary endpoint of 33.3% for LYNPARZA vs. 2.3% for abiraterone or enzalutamide in patients with BRCA1/2 or ATM mutations.

In an exploratory analysis of patients in the overall HRRm population, confirmed ORR was 21.7 % for LYNPARZA vs. 4.5% for patients receiving abiraterone or enzalutamide. The safety and tolerability profile of LYNPARZA in the PROfound trial was in line with that observed in prior clinical trials.

The most common adverse events greater than or equal to20% for LYNPARZA compared to abiraterone or enzalutamide were anemia, nausea, fatigue and asthenia, decreased appetite, and diarrhea. Grade 3 or above AEs were anemia, fatigue and asthenia, vomiting, dyspnea, urinary tract infection, nausea, decreased appetite, diarrhea, and back pain. AEs led to discontinuation of treatment in 16% of patients on LYNPARZA vs. 9% on abiraterone and enzalutamide.

AstraZeneca and Merck are also exploring additional trials in prostate cancer, including the ongoing Phase 3 PROpel trial, evaluating LYNPARZA as a first-line therapy in mCRPC for patients with or without HRR mutations, in combination with abiraterone acetate.

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Under Armour to cut global workforce by 3%

Under Armour rises after announcing 3% cut to global workforce

Stockwinners gives Stocks to Watch, Stocks to Buy, Stocks to Invest In, Stocks to buy on margin
Under Armour to cut global workforce by 3%

Shares of Under Armour (UA, UAA) are rising after the company provided an update on its restructuring plan and announced a roughly 3% cut to its workforce.

RESTRUCTURING PLAN

On Thursday, Under Armour announced an update to its 2018 restructuring plan and an approximately 3% cut to its global workforce.

Previously, the company expected to incur total estimated pre-tax restructuring and related charges of roughly $190M-$210M in connection with the plan but, following further evaluation, the company identified about $10M of cash severance charges related to the workforce reduction.

Accordingly, the company now expects approximately $200M-$220M of pre-tax restructuring and related charges to be incurred in 2018.

The reduction in workforce is expected to be completed by March 31, 2019 and represents the final component to the 2018 restructuring plan.

MANAGEMENT COMMENTS

“In our relentless pursuit of running a more operationally excellent company, we continue to make difficult decisions to ensure we are best positioned to succeed,” said Under Armour Chief Financial Officer David Bergman.

“This redesign will help simplify the organization for smarter, faster execution, capture additional cost efficiencies, and shift resources to drive greater operating leverage as we move into 2019 and beyond.”

GUIDANCE

Based on the operational efficiencies driven by the plan, the company now expects operating loss is to be approximately $60M versus the previous range of $50M-$60M. Excluding the impact of the restructuring plan, adjusted operating income is now expected to be $140M-$160M versus the prior expectation of $130M-$160M.

Excluding the impact of the restructuring efforts, adjusted earnings per share is now expected to be in the range of 16c-19c versus the previously expected range of 14c-19c. This compares to analyst estimates of 12c.

WHAT’S NOTABLE

Last year, Under Armour approved a restructuring plan to better align its financial resources to support the company’s efforts as the consumer landscape shifts.

As part of the plan, Under Armour said it was cutting about 2% of its global workforce of 15,000 and streamlining “all aspects” of the organization to improve business operations.

On Tuesday, Matt Powell, Senior Industry Advisor, Sports at The NPD Group, stated in a LinkedIn post that “As expected, August was a disappointing month for sport footwear. Sales were down low singles in dollars and in units, yielding a flat performance in average selling price.”

Powell noted that Nike (NKE) brand sales grew in the very low singles on strong lifestyle results, Adidas (ADDYY) sales grew “only in the low singles digits,” Skechers (SKX) athletic improved “in the low singles” and Under Armour footwear “declined more than 25%” last month.

PRICE ACTION

Class A Under Armour shares rose 4.4% to $19.58 in morning trading.


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Arconic higher following report of private equity interest

Arconic higher following report of private equity interest

Arconic higher following report of private equity interest, Stockwinners
Arconic higher following report of private equity interest, Stockwinners

Shares of Arconic (ARNC) are rising following a report that the aluminum producer has received interest from private equity firms including Apollo Global Management (APO).

PE  INTEREST

Arconic has received takeover interest from private-equity firms, including Apollo Global, The Wall Street Journal reported Friday.

A deal for the aerospace parts maker, which currently has a market value of $8.3B, could be worth over $10B, but no buyout agreement is imminent, the report said.

The company, which also holds $6.4B in debt, has a tumultuous recent history, facing an activist investor campaign from Elliott Management after being separated from the aluminum business now known as Alcoa (AA) in 2016.

The campaign led to the resignation of former Arconic Chief Executive Officer Klaus Kleinfeld and an overhaul of the company’s board.

In addition, the company came under scrutiny after investigators discovered its aluminum composite panels contributed to the spread of a fire last year at London’s Grenfell Tower that killed 80 people.

At the time, Arconic said it had no control over how its products were used in the building.

‘PLAUSIBLE LBO CANDIDATE’

Following the WSJ report, Morgan Stanley analyst Rajeev Lalwani said two things stand out to make Arconic a “plausible” leveraged buyout candidate: Its low EV/EBITDA multiple, which creates potentially favorable entry and exit points, and its cash flow profile, which has room for improvement.

The analyst stated that a more lean and efficient approach could support considerably better cash generation.

While the reported private equity interest “adds a level of intrigue,” Lalwani still believes headwinds within it rings and disks business, working capital and CapEx issues and volatility associated with aluminum prices will be the key driver of shares in the near-term.

Given the aforementioned execution concerns, Lalwani kept an Equal Weight rating and $20 price target on Arconic shares.

‘VERY VIABLE LBO CANDIDATE’

Credit Suisse analyst Curt Woodworth said he views Arconic as a “very viable” leveraged buyout candidate given its “highly depressed” multiples, operational and financial mismanagement, and “very strong” positions in automotive and aerospace end markets.

The analyst believes the issues at Firth Rixson are “very fixable” as the company is a new entrant into the disks market and said Arconic could be worth $24-$26 per share in a buyout. Woodworth has an Outperform rating on the shares with a $28 price target.

WHAT’S NOTABLE

On Monday, Arconic announced it had signed a new long-term contract with Boeing (BA) to supply aluminum sheet and plate for all models produced by Boeing Commercial Airplanes.

The multiyear contract, which extends and adds to the companies’ 2014 contract, is the largest to date and captures growth in the build rate increases of the Boeing 737 program.

PRICE ACTION

Arconic rose about 10%, or $1.73, to $19.12 in morning.


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21st Century Fox boosts it’s offer for Sky

21st Century Fox boosts offer for Sky to GBP 14 or $32.5B 

21st Century Fox boosts it's offer for Sky , Stockwinners
21st Century Fox boosts it’s offer for Sky , Stockwinners

21st Century Fox (FOXA) and the Independent Committee of Sky PLC (SKYAY) announced that they have reached agreement on an increased recommended pre-conditional cash offer for the fully diluted share capital of Sky which Fox and its affiliates do not already own at a price of GBP 14.00 for each Sky share.

The price of GBP 14.00 per Sky share represents an increase of approximately 12% to the Comcast (CMCSA) offer price of GBP 12.50 per Sky share announced on April 25, Fox says in a statement.

Under the terms of the increased offer, Sky shareholders will be entitled to receive for each Sky share GBP 14.00 in cash.

The increased price includes an amount in lieu of a final dividend in respect of the financial year ended June 30, 2018.

It is intended that the acquisition will be implemented by means of a scheme of arrangement under applicable U.K. law.

The Sky Independent Committee announced that it intends to unanimously recommend that the Sky shareholders unaffiliated with 21st Century Fox vote in favor of the scheme and take no action in relation to the Comcast offer.

Fox currently anticipates that the acquisition will complete in Q3 of 2018.

Fox added that the Sky acquisition is not a condition to completion of the Disney (DIS) transaction.

Completion of the Sky acquisition will not affect the amount or form of consideration that stockholders of 21st Century Fox receive in the Disney deal, it said.

“We strongly believe that a combined 21CF and Sky will be a powerful driver for the continued growth and vibrancy of the UK and broader global creative industries.

The enhanced scale and capabilities of the combination will enrich Sky’s ability to continue on its mission for years to come, especially at a time of dynamic change in our industry.

This transformative transaction will position Sky so that it can continue to compete within an environment that now includes some of the largest companies in the world, but none of whom have demonstrated the same local depth of investment and commitment to the UK and to Europe,” added Fox.


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BAE Systems receives contract for submarines

BAE Systems receives contract for payload tubes for Virginia-class submarines 

BAE Systems receives contract for submarines, Stockwinners
BAE Systems receives contract for submarines

BAE Systems (BAESY) has received a contract to produce payload tubes for two of the U.S. Navy’s new Virginia-class submarines to support increased firepower on the Block V version of the attack subs.

Under the contract with General Dynamics Electric Boat, a builder of the Virginia class, BAE Systems will deliver two sets, each consisting of four tubes, for the Virginia Payload Modules on the SSN 804 and SSN 805.

The Virginia Payload Module extends the length of the Block V submarines over previous versions of the Virginia-class by adding an additional mid-body section to create more payload space for greater firepower.

Each large-diameter payload tube can store and launch up to seven Tomahawk cruise missiles.

The VPM offers exceptional flexibility as well for the integration of future payload types, such as unmanned systems or next-generation weapons.

BAE Systems, which is also providing payload tubes for the SSN 803 under a previously awarded VPM contract, has a long history of supporting the Navy’s submarine fleet as the leading provider of propulsors and other submarine systems.

The company was selected to provide propulsors, spare hardware, and tailcones for Block IV Virginia-class vessels and stands ready to provide the same support for the Block V subs.

Under this most recent contract, BAE Systems will also develop the processes and tooling necessary for the Block V payload tube production.

Work will be performed at the company’s facility in Louisville, Kentucky, with deliveries scheduled to begin in 2020.

BAESY last traded at $35.39


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Merck says KEYTRUDA demonstrated long-term survival benefit

Merck says KEYTRUDA demonstrated long-term survival benefit

Merck says KEYTRUDA demonstrated long-term survival benefit, Stockwinners
Merck says KEYTRUDA demonstrated long-term survival benefit

Merck (MRK) announced long-term efficacy data from the Phase 3 KEYNOTE-006 study and the melanoma cohort of the Phase 1b KEYNOTE-001 study investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in patients with advanced melanoma.

KEYTRUDA is not chemotherapy or radiation therapy—it is an immunotherapy and it works with patient’s immune system to help fight certain cancers. KEYTRUDA can cause immune system to attack normal organs and tissues in any area of your body and can affect the way they work.

A new analysis from KEYNOTE-006 demonstrated durable efficacy benefits among patients who completed two years of KEYTRUDA treatment, combined with updated overall survival results across both studies, confirming anti-tumor activity in advanced melanoma patients.

At a median follow-up of 20.3 months after completion of KEYTRUDA in KEYNOTE-006, 86 percent of patients remained progression-free, the co-primary endpoint for the study.

For the primary endpoint of OS in KEYNOTE-006, the four-year OS rate was 41.7 percent in the pooled KEYTRUDA arms vs. 34.1 percent in the ipilimumab arm; in treatment-naive patients, OS rates were 44.3 percent in the pooled KEYTRUDA arms and 36.4 percent in the ipilimumab arm.

In KEYNOTE-001, the five-year OS rate, a secondary endpoint for the study, was 34 percent in all patients and 41 percent in treatment-naive patients.

The safety profile of KEYTRUDA in both studies was consistent with what has been seen in previous trials among patients with advanced melanoma.

KEYNOTE-006 is a global, open-label, randomized, pivotal, Phase 3 study evaluating KEYTRUDA compared to ipilimumab in patients with unresectable stage III or IV melanoma who had either not been treated previously or who had received a prior targeted therapy for BRAF-mutation positive melanoma/ The study randomized 834 patients to receive KEYTRUDA 10 mg/kg every three weeks, KEYTRUDA 10 mg/kg every two weeks, or four cycles of ipilimumab 3 mg/kg every three weeks.

Treatment continued until unacceptable toxicity or disease progression; patients without disease progression could be treated for up to 24 months.

Upon disease progression, eligible patients could receive an additional one year of KEYTRUDA. The co-primary endpoints were progression-free survival and OS; secondary endpoints were overall response rate, duration of response and safety, with an exploratory analysis for health-related quality of life.

With a median follow-up of 45.9 months, the four-year OS rate was 41.7 percent in the pooled KEYTRUDA arms and 34.1 percent in the ipilimumab arm; investigator-reported ORR was 42 percent and 17 percent, respectively.

Median DOR was not reached for KEYTRUDA or ipilimumab; 62 percent of patients in the KEYTRUDA arms and 59 percent of patients in the ipilimumab arm had a response lasting greater than or equal to 42 months.

In treatment-naive patients, the four-year OS rates were 44.3 percent in the pooled KEYTRUDA arms and 36.4 percent in the ipilimumab arm; ORR was 47 percent and 17 percent, respectively.

Median DOR was not reached for KEYTRUDA or ipilimumab; 65 percent of patients in the KEYTRUDA arms and 68 percent of patients in the ipilimumab arm had a response lasting greater than or equal to 42 months. Per study protocol, 18.5 percent of patients completed two years of KEYTRUDA.

With a median follow-up of 20.3 months 86 percent of patients remained progression-free. Eight patients received second-course KEYTRUDA; three discontinued treatment. Among the eight patients, there was one complete response and three partial responses; three patients had stable disease, while the remaining patient had progressive disease.

KEYNOTE-001 is a Phase 1b multicenter, open-label, multi-cohort trial evaluating KEYTRUDA in various advanced cancers, including 655 patients with advanced melanoma. Patients in the melanoma cohorts received 2 mg/kg or 10 mg/kg of KEYTRUDA every three weeks or 10 mg/kg of KEYTRUDA every two weeks until unacceptable toxicity or disease progression.

The primary endpoint was confirmed ORR. The secondary endpoints included PFS, OS and DOR. After median follow-up of 55 months, 35 patients remained on KEYTRUDA therapy.

The investigator-reported ORR, the primary endpoint for KEYNOTE-001, was 41 percent in all patients and 52 percent in treatment-naive patients.

The estimated five-year OS rate was 34 percent in all patients and 41 percent in treatment naive patients. Median OS was 23.8 months in all patients and 38.6 months in treatment-naive patients. Median PFS was 8.3 months and 16.9 months in all patients and treatment-naive patients, respectively. Median DOR was not reached in all responders and in treatment-naive patients; 73 percent of all responses and 82 percent of treatment-naive responses were ongoing at data cut-off.

The longest response observed in all patients was ongoing at 66 months.

The safety profile of KEYTRUDA was consistent with what has been seen in previously reported studies among patients with advanced melanoma. Treatment-related adverse events occurred in 86 percent of patients including 17 percent with grade 3-4 and eight percent who discontinued.

Twelve percent of patients experienced a serious TRAE including five percent who discontinued treatment. Immune-mediated adverse events and infusion reactions were reported in 23 percent of patients.

Most cases of immune-related adverse events, including hypothyroidism and pneumonitis, were grade 1 or 2. Hypothyroidism was the most commonly reported immune-mediated adverse event, followed by pneumonitis, colitis and skin disorders.

MRK closed at $60.56. It last traded at $61.65.


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Shire sold for $62 billion

Takeda reaches agreement to acquire Shire for $62B in cash and stock

Shire sold for $62 billion, Stockwinners
Shire sold for $62 billion, Stockwinners

Japan’s Takeda Pharmaceutical (TKPYY) and Shire (SHPG) announced that they have reached agreement on the terms of a recommended offer pursuant to which Takeda will acquire the entire issued and to be issued ordinary share capital of Shire.

Under the terms of the acquisition, each Shire shareholder will be entitled to receive $30.33 in cash for each Shire share and either 0.839 new Takeda shares or 1.678 Takeda ADSs. The transaction has been approved by both companies’ boards of directors, and is expected to close in the first half of calendar year 2019.

Upon the closing of the transaction, Takeda shareholders will own approximately 50% of the combined group. “With leading market positions in prioritized therapeutic areas, an attractive geographic footprint, greater scale and efficiencies, and an even more productive R&D engine, the combined group will be better positioned to deliver highly-innovative medicines and transformative care providing better health and a brighter future for patients around the world,” Takeda said.

Takeda has entered into a bridge facility agreement of $30.85B with, among others, J.P. Morgan Chase Bank, Sumitomo Mitsui Banking and MUFG Bank, part of the proceeds of which will be used to fund the cash consideration payable to Shire shareholders in connection with the acquisition.

It is currently contemplated that, prior to completion, the commitments under the bridge facility agreement will be reduced or refinanced with a combination of long-term debt, hybrid capital and available cash resources.

Shire plc, an Irish biotechnology company, researches, develops, licenses, manufactures, markets, distributes, and sells medicines for rare diseases and other specialized conditions worldwide.

Takeda Pharmaceutical Company Limited engages in the research and development, manufacture, marketing, and sale of pharmaceutical products worldwide. The company operates in three segments: Prescription Drug, Consumer Healthcare, and Other.


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Comcast offers to buy Sky News

Comcast announces GBP12.50 per share cash offer for Sky

Comcast tops Fox offer for Sky. Stockwinners.com
Comcast tops Fox offer for Sky

Comcast (CMCSA) published a Rule 2.7 announcement under the City Code on Takeovers and Mergers announcing its pre-conditional “superior” cash offer for the entire issued and to be issued share capital of Sky (SKYAY).

In the UK Announcement, Comcast announced that it intends to make the following commitments regarding Sky and investment in the UK: Maintain annual expenditure in Sky News for ten years, at a level not less than incurred in Sky’s 2017 financial year; Establish an editorial Sky News board with the responsibility to ensure the editorial independence of Sky News for ten years; Maintain Sky’s UK headquarters in Osterley for five years; and Not acquire any majority interest in UK newspapers for five years.

Additionally, Comcast reaffirmed the following statements of intention given in its Rule 2.4 announcement on February 27, 2018: Continue to support the creative industries in the UK and increase investment in UK film and TV production; Support innovation in the UK by continuing to support Sky’s technology hub in Leeds; Continue to support young people in the UK by maintaining Sky’s Software Engineering Academy scheme; and Continue to support Sky’s local community sports programs in the UK.

Comcast believes that, combined, Comcast and Sky will create a business equipped to compete more effectively in a rapidly changing and highly competitive industry.

Together, the companies would be well positioned to drive growth to provide attractive returns to Comcast shareholders and to benefit the employees and customers of both organizations.

Under the terms of the Acquisition, Sky shareholders will be entitled to receive GBP 12.50 in cash for each Sky share.

In addition, Sky shareholders shall be entitled to receive any final dividend in respect of Sky’s financial year ended June 30, 2018, up to an amount of 21.8 pence per Sky share, which is declared and paid prior to the Effective Date.

Comcast’s cash offer represents a 16 percent premium to the existing Twenty-First Century Fox, (FOXA) offer, and implies a value of $31 billion for the fully diluted share capital of Sky.

To provide financing in connection with the Acquisition, Comcast entered into an unsecured bridge credit agreement in an aggregate principal amount of up to GBP 16 billion and an unsecured term loan credit agreement in an aggregate principal amount of up to GBP 7 billion.

The Acquisition is subject to a number of pre-conditions and conditions as set forth in the UK Announcement, including receipt of antitrust and regulatory approvals and securing valid acceptances carrying in aggregate more than 50 percent of the voting rights then normally exercisable at a general meeting of Sky.


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GlaxoSmithKline acquires Novartis stake in Consumer Healthcare venture for $13B

GlaxoSmithKline acquires Novartis stake in Consumer Healthcare venture for $13B

GlaxoSmithKline acquires Novartis stake in Consumer Healthcare venture for $13B. Stockwinners.com
GlaxoSmithKline acquires Novartis stake in Consumer Healthcare venture for $13B

GlaxoSmithKline (GSK) announces that it has reached an agreement with Novartis (NVS) for the buyout of Novartis’ 36.5% stake in their Consumer Healthcare joint venture for $13B.

The Consumer Healthcare joint venture was formed as part of the three-part transaction between GSK and Novartis which was approved by shareholders in 2014.

Last year, GSK’s Consumer Healthcare business reported sales of GBP 7.8B.

Under the terms of the original transaction, Novartis has the right, exercisable from March 2, 2018 to March 2, 2035 to require GSK to purchase its stake in the joint venture.

“This put option, in both size and possible timing, creates inherent uncertainty for the Group’s capital planning. The new agreement to buy-out Novartis’ stake removes this uncertainty and improves the Group’s ability to plan allocation of capital to its other priorities,” the company said.

The business expects operating margins to approach “mid-20’s” percentages by 2022 at 2017 CER. The transaction is expected to be accretive to adjusted earnings in 2018 and thereafter, and is expected to “strengthen operational cash flows.”

GSK added, “Together with the Group’s new launch opportunities and expected operational improvements, these financial benefits further support GSK’s increased confidence in its ability to deliver its 2020 outlooks and invest effectively in the Group’s other priorities.”

The transaction is subject to approval by GSK shareholders as Novartis.

NVS closed at $79.68. GSK closed at $37.43.


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FDA proposed rules to lower nicotine in cigarettes

FDA takes steps to reduce smoking rates by lowering nicotine in cigarettes

FDA proposed rules to lower nicotine in cigarettes. Stockwinners.com
FDA proposed rules to lower nicotine in cigarettes

FDA Commissioner Scott Gottlieb earlier today issued a statement on steps to “dramatically reduce smoking rates by lowering nicotine in combustible cigarettes to minimally or non-addictive levels.”

The FDA issued an advance notice of proposed rulemaking, or ANPRM, to explore a product standard to lower nicotine in cigarettes to minimally or non-addictive levels.

“This new regulatory step advances a comprehensive policy framework that we believe could help avoid millions of tobacco-related deaths across the country,” Gottlieb said.

The ANPRM provides a “wide-ranging review of the current scientific understanding about the role nicotine plays in creating or sustaining addiction to cigarettes and seeks comments on key areas, as well as additional research and data for public review, as we continue our consideration of developing a nicotine product standard,” he added.

He went on, “We believe the public health benefits and the potential to save millions of lives, both in the near and long term, support this effort. Notably, new estimates included in the ANPRM that are being published in the New England Journal of Medicine evaluate one possible policy scenario for a nicotine product standard.

If this scenario were implemented, this analysis suggests that approximately 5 million additional adult smokers could quit smoking within one year of implementation.”

Publicly traded companies in the space include Altria Group (MO), British American Tobacco (BTI) and Philip Morris (PM). A beneficiary could be 22nd Century Group (XXII). The latter has a patent on a modified tobacco plant with 95% less nicotine than ordinary tobacco plants.


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Comcast tops Fox offer for Sky

Comcast tops Fox offer for Sky with $31B acquisition proposal 

Comcast tops Fox offer for Sky. Stockwinners.com
Comcast tops Fox offer for Sky

Comcast (CMCSA) announced a possible offer which it says is a “superior cash proposal” to acquire Sky (SKYAY).

Comcast’s announcement of a superior cash proposal of GBP 12.50 per share represents a 16% increase in value over the existing 21st Century Fox offer (FOXA) for Sky.

Comcast’s superior cash proposal implies an equity value of $31B for Sky.

“A combination would bring attractive financial benefits to Comcast shareholders, and is expected to be accretive to Comcast’s free cash flow per share in year one…The acquisition would enhance the entertainment, distribution, and technology leadership of Comcast, and importantly expand Comcast’s international footprint to more effectively compete in the rapidly changing and intensely competitive entertainment and communications landscape.

The combined business would create compelling opportunities for growth and innovation,” Comcast said in a statement.

“We think Sky is an outstanding company. It has 23 million customers and leading positions in the UK, Italy, and Germany. Sky has been a consistent innovator in its use of technology to deliver a fantastic viewing experience and has a proud record of investment in news and programming. It has great people and a very strong and capable management team.

Comcast intends to use Sky as a platform for growth in Europe. We already have a strong presence in London through our NBCUniversal international operations, and we intend to maintain Sky’s UK headquarters. Adding Sky to the Comcast family of businesses will increase our international revenues from 9% to 25% of Company revenues,” said Brian Roberts, CEO of Comcast.

SKYAYA closed at $61.60.


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Nektar receives $1.85 billion from Bristol-Myers

Bristol-Myers to pay Nektar $1.85B in cash, stock as part of collaboration pact

 

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Bristol-Myers to pay Nektar $1.85B in cash

Bristol-Myers Squibb (BMY) and Nektar Therapeutics (NKTR) announced the companies have executed a global strategic development and commercialization collaboration for Nektar’s lead immuno-oncology program, NKTR-214.

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Bristol-Myers to pay Nektar $1.85B in cash

Under the collaboration, the companies will jointly develop and commercialize NKTR-214 in combination with Bristol-Myers Squibb’s Opdivo and Opdivo plus Yervoy in more than 20 indications across 9 tumor types, as well as potential combinations with other anti-cancer agents from either of the respective companies and/or third parties.

NKTR-214, a CD122-biased agonist, is an investigational immuno-stimulatory therapy designed to selectively expand cancer-fighting T cells and natural killer cells directly in the tumor micro-environment and increase PD-1 expression on those immune cells.

Bristol-Myers Squibb and Nektar have agreed to a joint clinical development plan to evaluate NKTR-214 with Opdivo and Opdivo plus Yervoy in registration-enabling clinical trials in more than 20 indications in 9 tumor types including melanoma, renal cell carcinoma, non-small cell lung cancer, bladder and triple negative breast cancer.

Pivotal studies in renal cell carcinoma and melanoma are expected to be initiated in mid-2018.

Under the terms of the agreement, Bristol-Myers Squibb will make an upfront cash payment of $1.0B and an equity investment of $850M, or 8,284,600 shares of Nektar’s common stock at $102.60 per share.

Bristol-Myers Squibb has agreed to certain lock-up, standstill and voting provisions on its share ownership for a period of five years subject to certain specified exceptions.

Nektar is also eligible to receive an additional $1.78B in milestones, of which $1.43B are development and regulatory milestones and the remainder are sales milestones.

Nektar will book revenue for worldwide sales of NKTR-214 and the companies will split global profits for NKTR-214 with Nektar receiving 65% and Bristol-Myers Squibb 35%.

Bristol-Myers Squibb will retain 100% of product revenues for its own medicines.

The parties also will share development costs relative to their ownership interest of medicines included in the trials. For trials in the joint clinical development plan that include NKTR-214 with Opdivo only, the parties will share development costs with 67.5% allocated to Bristol-Myers Squibb and 32.5% allocated to Nektar.

For trials in the joint clinical development plan that include NKTR-214 with Opdivo and Yervoy, the parties will share development costs with 78% allocated to Bristol-Myers Squibb and 22% allocated to Nektar.

Both Bristol-Myers Squibb and Nektar have agreed for a specified period of time to not commence development with overlapping mechanisms of action in the same indications as those included in the joint clinical development plan.

The parties are otherwise free to develop NKTR-214 with their own pipeline assets and/or any other third party compounds. Both parties have agreed to initiate registration-enabling studies in the joint clinical development plan within 14 months of the effective date of the agreement, subject to allowable delays.

Both parties will jointly commercialize NKTR-214 on a global basis. Bristol-Myers Squibb will lead global commercialization activities for NKTR-214 combinations with Bristol-Myers Squibb medicines and Nektar will co-commercialize such combinations in the US, major EU markets and Japan.

Nektar will lead global commercialization activities for NKTR-214 combinations with either Nektar medicines and/or other third-party medicines.

For Bristol-Myers Squibb, the transactions are expected to be dilutive in 2018 and 2019 to the company’s non-GAAP EPS by 2c and 10c, respectively.

Nektar and Bristol-Myers Squibb currently expect to complete the transaction during the second quarter of 2018, subject to the expiration or termination of applicable waiting periods under all applicable US antitrust laws and the satisfaction of other usual and customary closing conditions.

Further details of the agreement can be found in Nektar’s Form 8-K filed today with the Securities and Exchange Commission. Nektar and Bristol-Myers Squibb entered into a clinical collaboration in September of 2016 to evaluate the potential for the combination of Opdivo and NKTR-214 to show improved and sustained efficacy and tolerability above the current standard of care.

The Phase 1/2 PIVOT clinical study is ongoing in over 350 patients with melanoma, kidney, non-small cell lung cancer, bladder, and triple-negative breast cancers.

NKTR closed at $75.66, it last traded at $69.97. BMY closed at $63.87. It last traded at $62.51.


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