Bristol-Myers comments on Celgene’s purchase

Bristol-Myers sees ‘meaningful financial benefits’ from Celgene transaction.

Bristol-Myers treatment for colorectal cancer approved, Stockwinners

Bristol Meyers Comments on Celgene purchase, Stockwinners

Bristol-Myers Squibb (BMY) said an updated its investor presentation about the Celgene (CELG) transaction.

The company said, “The Celgene transaction is the natural next step in Bristol-Myers Squibb’s proven strategy that has consistently delivered results for over a decade.

Through a disciplined approach to driving innovation, focusing on high-value opportunities and sourcing innovation externally to complement its internal portfolio and pipeline, Bristol-Myers Squibb has generated consistently strong growth and increased its dividend for 10 consecutive years.

The combination with Celgene will create a leading biopharma with increased scale, while maintaining the same agility and a focus on delivering for patients in core disease areas of high-unmet medical need.

The pipeline of the combined company provides significant near-, medium- and long-term opportunities for value creation. Bristol-Myers Squibb is acquiring Celgene’s robust and complementary pipeline at an attractive price.

In addition to six expected near-term product launches representing more than $15B in revenue potential, the combination will greatly increase Bristol-Myers Squibb’s Phase I and II assets, which will provide the next set of registrational opportunities in core therapeutic areas.

With an expanded set of scientific platforms and research capabilities, Bristol-Myers Squibb will be well positioned to discover and develop highly innovative medicines and accelerate these new options to patients through one of the highest-performing commercial organizations in the industry.

Bristol-Myers Squibb is well positioned for 2025 and beyond with continued leadership across Oncology and a diversified portfolio of assets.

The combined company will have a broad, balanced and earlier life-cycle marketed portfolio with a significantly higher number of opportunities across multiple diseases to drive the growth of Bristol-Myers Squibb in the second half of the decade. These opportunities will support financial strength for continued investment and innovation.

The Celgene transaction is expected to generate meaningful financial benefits for all stockholders.

With more than $45B of expected free cash flow generation over the first three full years post-closing, the combination will enable rapid debt reduction to de-lever the balance sheet and strengthen Bristol-Myers Squibb’s credit profile.

Bristol-Myers Squibb expects to realize run-rate cost synergies of approximately $2.5B by 2022 from the combination, and the combined company is expected to grow revenue and EPS every year through 2025.”

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Tesaro sold for $75 per share

Tesaro to be acquired by GSK for approx. $5.1B

 

Tesaro could be sold soon, Stockwinners
Tesaro sold for $75 per share, Stockwinners

GlaxoSmithKline (GSK) and TESARO (TSRO) announced that the companies have entered into a definitive agreement pursuant to which GSK will acquire TESARO, an oncology-focused company based in Waltham, Massachusetts, for an aggregate cash consideration of approximately $5.1B.

The proposed transaction significantly strengthens GSK’s pharmaceutical business, accelerating the build of GSK’s pipeline and commercial capability in oncology. The acquisition price of $75 per share in cash represents a 110% premium to TESARO’s 30 day Volume Weighted Average Price of $35.67 and an aggregate consideration of approximately $5.1B including the assumption of TESARO’s net debt.

Zejula’s revenues in its current approved indication as second-line maintenance treatment for ovarian cancer were $166 million for the 9 months ended 30 September 2018.

GSK expects the acquisition of TESARO and associated R&D and commercial investments will impact Adjusted EPS for the first two years by mid to high single digit percentages, reducing thereafter with the acquisition expected to start to be accretive to Adjusted EPS by 2022. GSK’s guidance for full-year 2018 Adjusted EPS growth remains unchanged at 8 to 10% at CER.

GSK continues to expect to deliver on its previously published Group Outlooks to 2020, but following the acquisition of TESARO now expects Adjusted EPS growth at CER for the period 2016-2020 to be at the bottom end of the mid to high single digit percentage CAGR range.

GSK confirms no change to its current dividend policy and continues to expect to pay 80p in dividends for 2018. GSK expects to fund the acquisition from cash resources and drawing under a new acquisition facility.

Please click here and read our blog when we predicted this transaction.


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Loxo Oncology shares higher on data

Loxo announces positive interim data from LOXO-292 dose escalation trial

Loxo Oncology presents positive data  at ASCO meeting

Loxo Oncology (LOXO) announced interim clinical data from the LOXO-292 global Phase 1 LIBRETTO-001 dose escalation trial.

LOXO-292 is an investigational, highly potent and selective RET inhibitor.

Resonance Energy Transfer (RET),  is a mechanism describing energy transfer between two chromophores.

These data are being presented at the 2018 American Society of Clinical Oncology Annual Meeting.

The LIBRETTO-001 Phase 1 trial contains a dose escalation phase and a dose expansion phase. The dose escalation phase follows a “3+3” design.

LOXO-292 is dosed orally in 28-day cycles. As dose cohorts are cleared, additional patients can enroll in these cleared cohorts.

Intra-patient dose escalation is also permitted as dose cohorts are cleared.

The primary endpoint of the trial is the determination of the maximum tolerated dose or recommended dose for further study.

Secondary endpoints include safety, overall response rate and duration of response. The dose expansion phase is designed to further characterize the overall response rate, durability of response, and safety of LOXO-292 in predefined groups of patients with activating RET alterations.

The data presented at ASCO were based on an April 2, 2018 data cut-off date.

Eighty-two total patients had been enrolled to eight dose escalation cohorts.

Pharmacokinetic analyses during the dose escalation demonstrated dose-dependent increases in LOXO-292 exposure with increasing dose.

Starting at the 40 mg BID dose and the 80 mg BID dose, respectively, LOXO-292 delivered sustained greater thanIC90 RET fusion and greater thanIC90 RET M918T-mutant target coverage, based on cell-based potencies.

Most treatment-emergent adverse events were Grade 1 in severity. The expansion cohorts of the LIBRETTO-001 trial are now open and enrolling at the 160 mg BID dose. This dose was selected for initial expansion based on its promising activity and tolerability profile.

Additional dose exploration above 160 mg BID is ongoing and patients enrolled to the expansion cohorts may dose escalate should a higher dose be advanced.

ANALYST COMMENTS

Citi analyst Yigal Nochomovitz raised his price target for Loxo Oncology to $235 saying the company is the “star of ASCO.” The analyst now believes LOXO-292 has advanced into an advantageous competitive position in RET fusions. He expects the shares to continue to trade up and keeps a Buy rating on Loxo.

Morgan Stanley analyst Matthew Harrison said he expects Loxo Oncology shares to trade near $200 in the wake of data on LOXO-292 presented at the ASCO meeting that he said “sets a high bar for competitors.” The data positions LOXO-292 to rapidly advance to registration, said Harrison, who raised his market share estimate for LOXO-292 to 70% from 60%, increased his LOXO-292 peak sales estimate to $1B from $700M, and lowered his risk-adjustment, all of which drove his price target on Loxo shares to $215 from $170. He maintains an Overweight rating on Loxo Oncology, which is up 13% to $210.50 in pre-market trading.

JMP Securities analyst Konstantinos Aprilakis said the Phase 1 study data presented on LOXO-292 in patients with RET-altered cancers at the ASCO meeting came in “far above expectations” with respect to both efficacy and safety. Citing the overall response rate in RET fusion cancers of 77%, Aprilakis called the efficacy data “exceedingly impressive” and increased his price target on Loxo Oncology to $221 from $182 following the presentation. Aprilakis maintains his Outperform rating on Loxo shares.


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Sorrento Therapeutics reports positive CAR-T cell therapy data

CAR-T cell therapy demonstrates therapeutic activity

CAR-T cell therapy demonstrates therapeutic activity. Stockwinners.com
CAR-T cell therapy demonstrates therapeutic activity

Sorrento Therapeutics (SRNE), cellular therapy focused subsidiary TNK Therapeutics and Surefire Medical announced initial results from the Hepatic ImmunoTherapy for Metastases-Surefire, or HITM-SURE, a Phase 1b single arm trial testing its autologous anti-CEA CAR-T cells administered regionally by hepatic artery infusion via pressure directed microvalve infusion technology in heavily pre-treated patients with refractory CEA-positive liver metastases.

This Phase 1b trial follows the HITM and HITM-SIR Phase 1 studies we believe demonstrated the safety and biological activity of the anti-CEA CAR-T administered with hepatic artery infusions alone or with selective internal radiotherapy.

The data of HITM-SURE were provided by Dr. Steven Katz, the Principal Investigator of the Study and Associate Professor of Surgery at The Roger Williams Medical Center.

The study is also open at Colorado University and funded in part by the Colorado Office for Economic Development and International Trade. In total, three patients have completed the ongoing HITM-SURE protocol, two with stage IV pancreatic cancer and one with colorectal cancer.

All patients presented with unresectable, chemotherapy refractory CEA+ liver metastases. Patients received three HAI of anti-CEA CAR-T cells along with low dose IL-2 infusion. CAR-T HAI were administered via a Surefire MVI technology. The primary objective of the study was to establish the safety of the CAR-T HAI with the pressure directed MVI device.

Secondary objectives included response assessed by modified RECIST, immune-related response criteria, and tumor marker kinetics. Reduction in post-treatment serum CEA was noted in all patients.

Two patients have progressive disease, with a pancreatic cancer patient alive at 7 months and a colorectal cancer patient alive at 4.8 months. A patient with stage IV pancreas adenocarcinoma has no evidence of liver metastases 11 months on PET scan following three CAR-T HAIs.

In the phase III MPACT study, treatment of stage IV pancreas adenocarcinoma patients with gemcitabine plus albumin-bound paclitaxel resulted in a median overall survival time of 8.7 months.

It will be of interest to determine if the results from upcoming phase 2 liver metastasis HITM studies will confirm the encouraging results from our small number of patients.

The initial findings from the currently enrolling HITM-SURE trial follows the results of two other trials. In one of the previous trials, a patient survived 51 months following 3 anti-CEA CAR-T HAIs and a patient from another trial is alive 25 months after treatment.

SRNE closed at $7.20.


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Kite and Sangamo to develop engineered cell therapies

Kite, Sangamo announce collaboration to develop engineered cell therapies

Kite, Sangamo to develop engineered cell therapies. Stockwinners.com
Kite, Sangamo to develop engineered cell therapies

Kite, a Gilead Company (GILD) and Sangamo Therapeutics (SGMO) announced the companies have entered into a worldwide collaboration using Sangamo’s zinc finger nuclease technology platform for the development of next-generation ex vivo cell therapies in oncology.
Ex vivo cell therapy is in essence gene therapy delivered by transfer of therapeutic genes to cells in culture, which are then given to the patient to treat fatal infections such as AIDS, or other conditions such as cancer or genetic diseases.

 

These manipulations include the purification and culture of therapeutic cell subtypes, as well as elimination of cells which cause disease (cancer cells or immune cells reacting to the body itself). Gene therapy can be delivered by transfer of therapeutic genes to cells in culture, which are then given to the patient to treat fatal infections such as AIDS, cancer or genetic diseases.

 

Kite will use Sangamo’s ZFN technology to modify genes to develop next-generation cell therapies for autologous and allogeneic use in treating different cancers.

 

Allogeneic cell therapies from healthy donor cells or from renewable stem cells would provide a potential treatment option that can be accessed directly within the oncology infusion center, thus reducing the time to infusion for patients.

 

Under the terms of the agreement, Sangamo will receive an upfront payment of $150M and is eligible to receive up to $3.01B in potential payments, aggregated across 10 or more products utilizing Sangamo’s technology, based on the achievement of certain research, development, regulatory and successful commercialization milestones.

 

Sangamo would also receive tiered royalties on sales of potential future products resulting from the collaboration. Kite will be responsible for all development, manufacturing and commercialization of products under the collaboration, and will be responsible for agreed upon expenses incurred by Sangamo.

 

This transaction is subject to clearance under the Hart-Scott Rodino Antitrust Improvements Act and other customary closing conditions.

 

A Current Report on Form 8-K describing the proposed transaction in more detail will be filed by Sangamo, and this press release is subject to further detail provided in Sangamo’s 8-K.

 

Separately, Sangamo reported Q4 EPS (15c) vs consensus (18c) – Reported Q4 revenue $13.1M, consensus $11.43M.


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Pieris Pharmaceuticals higher on collaboration with Seattle Genetics

Pieris Pharmaceuticals, Seattle Genetics enter collaboration, license agreement

Pieris Pharmaceuticals higher on collaboration with Seattle Genetics
Pieris Pharmaceuticals higher on collaboration with Seattle Genetics

Pieris Pharmaceuticals (PIRS) and Seattle Genetics (SGEN) announced they have entered into a collaboration and license agreement with the goal of developing multiple targeted bispecific immuno-oncology treatments for solid tumors and blood cancers.

The collaboration leverages the expertise and core technologies of both companies to develop novel Antibody-Anticalin fusion proteins.

Under the terms of the agreement, Seattle Genetics will pay Pieris a $30M upfront fee, tiered royalties on net sales up to low double-digits, and up to $1.2B in total success-based payments across three product candidates.

The companies will pursue multiple Antibody-Anticalin fusion proteins during the research phase, and Seattle Genetics has the option to select up to three therapeutic programs for further development.

Prior to the initiation of a pivotal trial, Pieris may opt into global co-development and US commercialization of the second program and share in global costs and profits on a 50/50 basis.

Seattle Genetics will solely develop, fund and commercialize the other two programs.

PIRS closed at $7.14. It last traded at $8.32.


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Ablynx sold for EUR 3.9 billion

Sanofi acquires Ablynx for EUR 45 per share or EUR 3.9B

 Novo Nordisk offers to acquire Ablynx. Stockwinners.com
Sanofi acquires Ablynx for EUR 45 per share

Sanofi (SNY) and Ablynx (ABLX) entered into a definitive agreement under which Sanofi will offer to acquire all of the outstanding ordinary shares, including shares represented by American Depositary Shares, warrants and convertible bonds of Ablynx at a price per Ablynx share of EUR 45 in cash, which represents an aggregate equity value of approximately EUR 3.9B.

The transaction was unanimously approved by both the boards. Under the terms of the agreement, Sanofi will launch public offers to acquire all of the outstanding ordinary shares, warrants and convertible bonds of Ablynx in cash.

The public offers are expected to be launched by the beginning of Q2.

In accordance with the Belgian requirement of certainty of funds, Sanofi has entered into a bank credit facility, BNP Paribas Fortis acting as the sole credit facility arranger.

Subject to the satisfaction or waiver of customary closing conditions, the transaction is expected to close by the end of Q2. Sanofi added, “The addition of Ablynx is anticipated to drive meaningful long-term value for Sanofi’s shareholders by enhancing its pipeline and research capabilities. Including R&D expenses, the acquisition is expected to be neutral to Business EPS in 2018 and 2019.”


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EMA rejects Puma’s neratinib, Shares tumble

Puma says EMA communicates negative trend vote over MAA for neratinib

sTOCKS TO WATCH, FDA Approves Breast Cancer Drug. See Stockwinners.com Market Radar, Stocks to Buy, Stocks to Invest In, Stocks to Buy on Margin
EMA rejects Breast Cancer Drug!

Puma Biotechnology (PBYI) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has communicated a negative trend vote after meeting with the company today to discuss the Marketing Authorisation Application for neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer.

 

A negative trend vote means it is unlikely that CHMP will provide a positive opinion related to the Company’s MAA at the formal CHMP decision vote scheduled in February 2018, and that additional steps would need to be taken to gain marketing approval in Europe.

 

CHMP indicated that, in its opinion, the benefit risk assessment is negative as the study results are based on evidence from a single pivotal trial and the 2- and 5-year invasive disease free survival benefits observed to-date may lack sufficient clinical relevance.

 

CHMP’s opinion was based on the results from both the Phase III ExteNET trial in extended adjuvant early stage HER2-positive breast cancer and the Phase II CONTROL trial in extended adjuvant early stage HER2-positive breast cancer.

BACKGROUND

 On July 17, 2017, the company announced that the U.S. FDA has approved #NERLYNX (neratinib), formerly known as #PB272, a once-daily oral tyrosine kinase inhibitor for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy. The drug became commercially available in September of 2017 under the trade name as NERLYNX.

EUROPEAN  DATA 

Last September, Puma Biotechnology (PBYI) presented positive results from the Phase III clinical trial of Puma’s drug neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer following trastuzumab-based therapy in a proffered paper oral session at the European Society of Medical Oncology 2017 Congress in Madrid, Spain.

PRICE ACTION

Today’s EMA decision was a surprise to the market. PBYI closed at $90.90. Shares last traded at $66.00 in extended trading.

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