On August 23, 2016 Bristol-Myers Squibb Company (link is external) (NYSE: BMY) and Pfizer Inc.(NYSE: PFE) reported that 19 abstracts (late-breaking, rapid-fire, oral and poster presentations) will be presented at ESC Congress 2016, to be held August 27–31 in Rome, Italy (Press release, Pfizer, AUG 23, 2016, View Source [SID:1234514680]). These new data from post-hoc analyses from ARISTOTLE (Apixaban for Reduction In STroke and Other ThromboemboLic Events in Atrial Fibrillation) and retrospective real-world data analyses continue to underscore the Alliance’s commitment to the evaluation of Eliquisfor patients with nonvalvular atrial fibrillation (NVAF) and venous thromboembolism (VTE). Of note, several of the real-world data analyses are part of ACROPOLIS (Apixaban ExperienCe Through Real-WOrld POpuLatIon Studies), a global real-world data research program designed to further evaluate the effectiveness and safety of apixaban in routine clinical practice.

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"The Bristol-Myers Squibb and Pfizer Alliance is pleased to share 19 abstracts, which include new real-world analyses, as well as new sub-analyses from the pivotal Phase 3 ARISTOTLE trial," said Rory O’Connor, M.D., Chief Medical Officer, Internal Medicine, Pfizer Innovative Health. "We look forward to the opportunity to contribute to the scientific discussion and continued research during ESC Congress 2016."

"As patient and provider needs continue to evolve, it’s essential that we deepen our understanding of how medicines are working in real-world situations," said Jack Lawrence, M.D., Vice President, Cardiovascular Specialty Development, Bristol-Myers Squibb. "This year at ESC Congress 2016, we’ll be discussing new NVAF and VTE data that complement our robust body of clinical trial data."

The complete list of Bristol-Myers Squibb and Pfizer Alliance presentations is included below. Abstracts can be accessed on the ESC Congress 2016 website (link is external).

Title Presenting Author/Type Date/Time (BST) Location/Session
Phase 3 Clinical Trial Sub-Analyses
Patients with Atrial Fibrillation and History of Falls Are at High Risk for Bleeding but Have Less Bleeding with Apixaban than Warfarin: Results from the ARISTOTLE Trial
Session: New Trends in Antithrombotic Therapy for Atrial Fibrillation
Rao et al. /
Oral, Rapid Fire
Aug. 28,
11:10
Agora 1 – Poster Area
Efficacy and Safety of Apixaban versus Warfarin in Patients with Atrial Fibrillation and Active Cancer: Insights from the ARISTOTLE Trial
Session: New Trends in Antithrombotic Therapy for Atrial Fibrillation
Melloni et al. /
Oral, Rapid Fire
Aug. 28,
11:20
Agora 1 – Poster Area
Patients with Atrial Fibrillation Treated with Apixaban Are Less Likely to Discontinue Study Drug When Compared with Warfarin: Insights from the ARISTOTLE Trial
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation III

Xavier et al. /
Poster
Aug. 28,
14:00
Poster Area
Real-World Data and Other Analyses
Contemporary Results from EHR Study of Real-World Bleeding Risk among Elderly and Overall Non-Valvular Atrial Fibrillation Patients Prescribed Apixaban, Dabigatran, Rivaroxaban and Warfarin
Session: New Trends in Antithrombotic Therapy for Atrial Fibrillation
Horblyuk et al. /
Oral, Rapid Fire
Aug. 28,
12:00
Agora 1 – Poster Area
Real-World Comparisons of Major Bleeding Risk and Major Bleeding-Related Hospitalization Costs among Elderly Non-Valvular Atrial Fibrillation Patients Newly Initiated on Apixaban or Warfarin
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation

Lip et al. /
Poster
Aug. 28,
14:00
Poster Area
Is Major Bleeding Risk for Oral Anticoagulants Similar Between Non-Valvular Atrial Fibrillation Patients Newly Initiated on Warfarin and Propensity-Score Matched NOAC Initiators? A Real World Study
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation
Lip et al. /
Poster
Aug. 28,
14:00
Poster Area
Major Bleeding Risk in Patients 75 Years of Age or Older with Non-Valvular Atrial Fibrillation Initiating Oral Anticoagulants: A ‘Real-World’ Comparison of Warfarin, Apixaban, Dabigatran, or Rivaroxaban
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation II

Lip et al. /
Poster
Aug. 28,
14:00
Poster Area
Is There a Difference in Treatment Persistence Across Oral Anticoagulants? Results of a UK Cohort Study Evaluating Oral Anticoagulation Therapy in an Atrial Fibrillation Population
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation
Stynes et al. /
Poster
Aug. 28,
14:00
Poster Area
Real-World Comparison of Major Bleeding and Associated Costs among Treatment-Naïve Non-Valvular Atrial Fibrillation Patients Initiating Apixaban or Warfarin
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation II
Trocio et al. /
Poster
Aug. 28,
14:00
Poster Area
Aspirin, not without Bleeding Risk in the Real World: Results of a UK Cohort Study Evaluating the Use of Antiplatelet Therapy for Stroke Prevention in Atrial Fibrillation (AF)
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation III
Ridha et al. / Poster
Aug. 28,
14:00
Poster Area
Is Aspirin Monotherapy Effective for Stroke Prevention in the Real World? A UK Cohort Study Evaluating the Incidence of Stroke in the Absence of Anticoagulation in Atrial Fibrillation (AF)
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation II
Ridha et al. /
Poster
Aug. 28,
14:00
Poster Area
Differences in the Characteristics of Patients with Non-Valvular Atrial Fibrillation Who Are Newly Prescribed Apixaban, Rivaroxaban, Dabigatran and VKA in General Practice in the UK
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation

Stynes et al. /
Poster
Aug. 28,
14:00
Poster Area
Risk of Bleeding with Non-Vitamin K Antagonists and Phenprocoumon in Routine Care Patients with Non-Valvular Atrial Fibrillation
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation III

Hohnloser et al. /
Poster
Aug. 28,
14:00
Poster Area
Are Your Atrial Fibrillation (AF) Patients Protected from Ischaemic Stroke? Clinical Characteristics of AF Patients Eligible for Stroke Prevention but Remaining Untreated in UK Clinical Practice
Session: Poster Session 3: Anticoagulation in Atrial Fibrillation II

Ridha et al. /
Poster
Aug. 28,
14:00
Poster Area
Bleeding Risk for Non-Valvular AF Patients Prescribed Warfarin, or Standard Doses of Apixaban 5mg BID, Dabigatran 150mg BID or Rivaroxaban 20mg QD in Real-World Practice: Findings from EHR
Session: Are You Still Afraid about Bleeding Risk of Antithrombotic Therapy in Atrial Fibrillation?
Lip et al. /
Oral, Advances in Science
Aug. 28,
14:18
Minsk – Village 4
Demographic and Clinical Characteristics Associated with Initiation of Individual Oral Anticoagulants among Patients with Newly Diagnosed Venous Thromboembolism
Session: Poster Session 4: Thrombosis and Coagulation
Li et al. /
Poster
Aug. 29,
08:30
Poster Area
A Nationwide Register Study to Compare Bleeding Rates in Patients with Non-Valvular Atrial Fibrillation Prescribed Oral Anticoagulants
Session: Registries Atrial Fibrillation

Halvorsen et al. /
Late-Breaker
Aug. 29,
08:45
Raphael – The Hub
Costs of Major Adverse Outcomes in Patients with Incident Venous Thromboembolism in Clinical Practice in the United Kingdom
Session: Advances in Pulmonary Embolism

Cohen et al. /
Poster
Aug. 29,
16:03
Moderated Poster Station – Poster Area
Potential Impact of Apixaban on Hospital Resource Use in Patients with Venous Thromboembolism
Session: Antithrombotics in Daily Clinical Practice
Li et al. /
Oral, Rapid Fire
Aug 30,
17:24
Galileo – The Hub
About Eliquis

Eliquis (apixaban) is an oral selective Factor Xa inhibitor. By inhibiting Factor Xa, a key blood clotting protein, Eliquisdecreases thrombin generation and blood clot formation. Eliquis is approved for multiple indications in the U.S. based on efficacy and safety data from seven Phase 3 clinical trials. Eliquis is a prescription medicine indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF); for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery; for the treatment of DVT and PE; and to reduce the risk of recurrent DVT and PE, following initial therapy.

ELIQUIS Indications and Important Safety Information

Indications

ELIQUIS is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

ELIQUIS is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

ELIQUIS is indicated for the treatment of DVT and PE, and to reduce the risk of recurrent DVT and PE following initial therapy.

ELIQUIS Important Safety Information

WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA

(A) Premature discontinuation of any oral anticoagulant, including ELIQUIS, increases the risk of thrombotic events. If anticoagulation with ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.

(B) Epidural or spinal hematomas may occur in patients treated with ELIQUIS who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:
use of indwelling epidural catheters
concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants
a history of traumatic or repeated epidural or spinal punctures
a history of spinal deformity or spinal surgery
optimal timing between the administration of ELIQUIS and neuraxial procedures is not known

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.

Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated.
CONTRAINDICATIONS

Active pathological bleeding
Severe hypersensitivity reaction to ELIQUIS (e.g., anaphylactic reactions)
WARNINGS AND PRECAUTIONS

Increased Risk of Thrombotic Events after Premature Discontinuation: Premature discontinuation of any oral anticoagulant, including ELIQUIS, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from ELIQUIS to warfarin in clinical trials in atrial fibrillation patients. If ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.
Bleeding Risk: ELIQUIS increases the risk of bleeding and can cause serious, potentially fatal, bleeding.
Concomitant use of drugs affecting hemostasis increases the risk of bleeding, including aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, SSRIs, SNRIs, and NSAIDs.
Advise patients of signs and symptoms of blood loss and to report them immediately or go to an emergency room. Discontinue ELIQUIS in patients with active pathological hemorrhage.
There is no established way to reverse the anticoagulant effect of apixaban, which can be expected to persist for at least 24 hours after the last dose (i.e., about two half-lives). A specific antidote for ELIQUIS is not available.
Spinal/Epidural Anesthesia or Puncture: Patients treated with ELIQUIS undergoing spinal/epidural anesthesia or puncture may develop an epidural or spinal hematoma which can result in long-term or permanent paralysis.
The risk of these events may be increased by the postoperative use of indwelling epidural catheters or the concomitant use of medicinal products affecting hemostasis. Indwelling epidural or intrathecal catheters should not be removed earlier than 24 hours after the last administration of ELIQUIS. The next dose of ELIQUIS should not be administered earlier than 5 hours after the removal of the catheter. The risk may also be increased by traumatic or repeated epidural or spinal puncture. If traumatic puncture occurs, delay the administration of ELIQUIS for 48 hours.

Monitor patients frequently and if neurological compromise is noted, urgent diagnosis and treatment is necessary. Physicians should consider the potential benefit versus the risk of neuraxial intervention in ELIQUIS patients.

Prosthetic Heart Valves: The safety and efficacy of ELIQUIS have not been studied in patients with prosthetic heart valves and is not recommended in these patients.
Acute PE in Hemodynamically Unstable Patients or Patients who Require Thrombolysis or Pulmonary Embolectomy: Initiation of ELIQUIS is not recommended as an alternative to unfractionated heparin for the initial treatment of patients with PE who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.
ADVERSE REACTIONS

The most common and most serious adverse reactions reported with ELIQUIS were related to bleeding.
TEMPORARY INTERRUPTION FOR SURGERY AND OTHER INTERVENTIONS

ELIQUIS should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. ELIQUIS should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be noncritical in location and easily controlled. Bridging anticoagulation during the 24 to 48 hours after stopping ELIQUIS and prior to the intervention is not generally required. ELIQUIS should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established.
DRUG INTERACTIONS

Strong Dual Inhibitors of CYP3A4 and P-gp: Inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp) increase exposure to apixaban and increase the risk of bleeding. For patients receiving ELIQUIS doses of 5 mg or 10 mg twice daily, reduce the dose of ELIQUIS by 50% when ELIQUIS is coadministered with drugs that are strong dual inhibitors of CYP3A4 and P-gp (e.g., ketoconazole, itraconazole, ritonavir, or clarithromycin). In patients already taking 2.5 mg twice daily, avoid coadministration of ELIQUIS with strong dual inhibitors of CYP3A4 and P-gp.
Strong Dual Inducers of CYP3A4 and P-gp: Avoid concomitant use of ELIQUIS with strong dual inducers of CYP3A4 and P-gp (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort) because such drugs will decrease exposure to apixaban and increase the risk of stroke and other thromboembolic events.
Anticoagulants and Antiplatelet Agents: Coadministration of antiplatelet agents, fibrinolytics, heparin, aspirin, and chronic NSAID use increases the risk of bleeding. APPRAISE-2, a placebo-controlled clinical trial of apixaban in high-risk post-acute coronary syndrome patients treated with aspirin or the combination of aspirin and clopidogrel, was terminated early due to a higher rate of bleeding with apixaban compared to placebo.
PREGNANCY CATEGORY B

There are no adequate and well-controlled studies of ELIQUIS in pregnant women. Treatment is likely to increase the risk of hemorrhage during pregnancy and delivery. ELIQUIS should be used during pregnancy only if the potential benefit outweighs the potential risk to the mother and fetus.
Please see full Prescribing Information, including BOXED WARNINGS and Medication Guide, available atwww.bms.com (link is external).

About ACROPOLIS

ACROPOLIS (Apixaban ExperienCe Through Real-WOrld POpuLatIon Studies) is the Eliquis (apixaban) global real-world data program designed to generate additional evidence from routine clinical practice settings to further inform healthcare decision makers, including healthcare providers and payers. The ACROPOLIS program will include retrospective, outcomes-based analyses from over 10 databases around the world, including medical records, medical and pharmacy health insurance claims data, and national health data systems.

Analyses of real-world data allow for a broader understanding of patient outcomes associated with Eliquis outside of the clinical trial setting, as well as insight into other measures of healthcare delivery, such as hospitalization and costs.

About ARISTOTLE

ARISTOTLE (Apixaban for Reduction In STroke and Other ThromboemboLic Events in Atrial Fibrillation) was designed to evaluate the efficacy and safety of Eliquis versus warfarin for the prevention of stroke or systemic embolism. In ARISTOTLE, 18,201 patients were randomized (9,120 patients to Eliquis and 9,081 to warfarin). ARISTOTLE was an active-controlled, randomized, double-blind, multi-national trial in patients with nonvalvular atrial fibrillation or atrial flutter, and at least one additional risk factor for stroke. Patients were randomized to treatment with Eliquis 5 mg orally twice daily (or 2.5 mg twice daily in selected patients, representing 4.7 percent of all patients) or warfarin (target INR range 2.0-3.0), and followed for a median of 1.8 years.

About the Bristol-Myers Squibb/Pfizer Collaboration

In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize apixaban, an oral anticoagulant discovered by Bristol-Myers Squibb. This global alliance combines Bristol-Myers Squibb’s long-standing strengths in cardiovascular drug development and commercialization with Pfizer’s global scale and expertise in this field.

As disclosed in its Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2016, on August 3, 2016, Momenta Pharmaceuticals, Inc. (the "Company") discontinued further accrual of its Part B, or Phase 2, portion of its Phase 1/2 clinical trial evaluating necuparanib in combination with nab-paclitaxel (ABRAXANE) and gemcitabine in patients with advanced metastatic pancreatic cancer. The decision to discontinue enrollment was based on the recommendation of the independent Data Safety Monitoring Board for the trial following the outcome of a planned interim futility analysis. On August 22, 2016, after confirming the results of the futility analysis and reviewing the unblinded safety and efficacy data and the results of various sensitivity and subgroup analyses, the Company decided to discontinue the necuparanib program.

On February 29, 2016, the Company filed with the Securities and Exchange Commission (the "Commission") a shelf registration statement on Form S-3 (File No. 333-209813) (the "Registration Statement"), which became immediately effective upon filing.

On September 1, 2016, the Company will be filing with the Commission a prospectus supplement, dated September 1, 2016, to the prospectus included in the Registration Statement in connection with the offer and sale of shares of the Company’s common stock from time to time through Stifel, Nicolaus & Company, Incorporated ("Stifel"), pursuant to an At-the-Market Equity Offering Sales Agreement, dated April 21, 2015, between the Company and Stifel, which was filed with the Commission as Exhibit 10.1 to the Company’s Current Report on Form 8-K on April 21, 2015.

In connection with the filing of the prospectus supplement, the Company is filing as Exhibit 5.1 hereto a copy of an opinion of its counsel, Latham & Watkins LLP, regarding the validity of the securities being registered under the prospectus supplement.

On August 22, 2016 Foundation Medicine, Inc. (NASDAQ:FMI) reported the addition of new clinical markers to its FoundationOne and FoundationOne Heme products, which are designed to enhance oncologists’ insight into potential response to immunotherapies (Press release, Foundation Medicine, AUG 22, 2016, View Source [SID:1234514660]). This ability to determine TMB and MSI from its assays is additional to the existing comprehensive profiling of genes provided by FoundationOne and FoundationOne Heme. Taken together, the molecular information provided by Foundation Medicine provides unique insights to physicians and enhances their ability to predict response to immunotherapies, identify targeted therapeutic options, and improve access to clinical trials all from a single assay.

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"Cancer immunotherapies are at the forefront of cancer treatment, and new, quantitative approaches are needed to predict clinical responses to this important, but also expensive, class of therapies," said Vincent Miller, M.D., chief medical officer of Foundation Medicine. "Prior to our ability to measure TMB and MSI with FoundationOne, these biomarkers could only be detected separately, either through tests such as immunohistochemistry, polymerase chain reaction (PCR) or whole exome sequencing. Importantly, high-quality, predictive TMB scoring can only be accurately performed with sophisticated algorithms developed to work with broad, hybrid capture-based platforms that can analyze all relevant alterations simultaneously. Integrating this capability to measure TMB and MSI with one tissue sample, and reported in one test, represents an important advance in clinical care."

A growing body of evidence, most recently presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting this year, validates the ability of a new independent marker, TMB, to predict the likelihood of response to cancer immunotherapies. TMB is reported as the total number of DNA mutations per megabase in a tumor sequence. This phenomenon has been validated across a wide range of tumor types, including advanced bladder cancer, lung cancer, breast cancer, colorectal cancer, advanced head and neck cancer and melanoma. Some tumors develop high TMB as a result of defective mismatch repair of DNA, a condition in which the length of certain DNA areas becomes more widely varied than normal. This condition, which is referred to as MSI-high and MSI-high tumors, almost always has a high TMB.

"The ability to accurately measure multiple biomarkers simultaneously, including TMB and MSI, is an important advance for the field of cancer immunotherapy, and one that is unique to Foundation Medicine," said Thomas George, M.D., GI oncology program director, University of Florida. "Foundation Medicine’s combination of advanced sequencing platforms and highly-specific algorithms gives me access to all relevant genomic biomarkers for my patients at once, helping to save both time and tissue."

"We were encouraged by the findings presented at ASCO (Free ASCO Whitepaper), including the possibility of identifying patients more likely to benefit from checkpoint inhibitor immunotherapy," said Dr. Miller. "Our goal is to empower doctors and patients with a full range of relevant, actionable genomic information, and we’re excited to offer our distinctive solution to estimate TMB and MSI simultaneously and with exceptional accuracy, supported by sophisticated algorithms and rooted in contextual insights from our knowledgebase FoundationCORE. This is something no other next-generation sequencing platform offers."

Independent of the FoundationOne and FoundationOne Heme assays, Foundation Medicine also offers testing for PD-1 and PD-L1 protein expression, providing, in combination with the FoundationOne assays, a full suite of cancer immunotherapy assays for oncologists.

On August 22, 2016 Pfizer Inc. (NYSE:PFE) and Medivation, Inc. (NASDAQ:MDVN) reported that they have entered into a definitive merger agreement under which Pfizer will acquire Medivation, a biopharmaceutical company focused on developing and commercializing small molecules for oncology, for $81.50 a share in cash for a total enterprise value of approximately $14 billion (Press release, Medivation, AUG 22, 2016, View Source [SID:1234514661]). The Boards of Directors of both companies have unanimously approved the merger, which is expected to be immediately accretive to Pfizer’s Adjusted Diluted EPS upon closing, approximately $0.05 accretive in the first full year after close with additional accretion and growth anticipated thereafter. Pfizer does not expect the transaction to impact its current 2016 financial guidance.

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"The proposed acquisition of Medivation is expected to immediately accelerate revenue growth and drive overall earnings growth potential for Pfizer," said Ian Read, chairman and chief executive officer, Pfizer. "The addition of Medivation will strengthen Pfizer’s Innovative Health business and accelerate its pathway to a leadership position in oncology, one of our key focus areas, which we believe will drive greater growth and scale of that business over the long-term. This transaction is another example of how we are effectively deploying our capital to generate attractive returns and create shareholder value."

Medivation’s portfolio includes XTANDI (enzalutamide), an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within the tumor cell. XTANDI is the leading novel hormone therapy in the United States today and generated approximately $2.2 billion in worldwide net sales over the past four quarters, as recorded by Astellas Pharma Inc., with whom Medivation entered an agreement in 2009 to develop XTANDI globally and commercialize jointly in the U.S. Since its approval for advanced metastatic prostate cancer by the U.S. Food and Drug Administration in 2012, XTANDI has treated 64,000 men to date in the U.S. alone. Medivation and Astellas have built a robust development program for XTANDI, including two Phase 3 studies in non-metastatic prostate cancer and another Phase 3 study in hormone-sensitive prostate cancer. It is also being further developed in Phase 2 studies for the potential treatment of advanced breast cancer and hepatocellular carcinoma.

In addition, Medivation has a promising, wholly-owned, late-stage oncology pipeline, which includes two development-stage oncology assets, talazoparib and pidilizumab. Talazoparib, currently in a Phase 3 study for the treatment of BRCA-mutated breast cancer, has the potential to be a highly potent PARP inhibitor and could be efficacious across several additional tumors. Pidilizumab is an immuno-oncology (IO) asset being developed for diffuse large B-cell lymphoma and other hematologic malignancies and has the potential to be combined with IO therapies in Pfizer’s portfolio.

"We believe the combination with Pfizer is the right next step in our growth trajectory and is a testament to the passion and dedication by which the Medivation team has delivered on our mission to profoundly transform patients’ lives through medically innovative therapies," said David Hung, M.D., founder, president and CEO of Medivation. "This compelling transaction will deliver significant and immediate value to our stockholders and provides new opportunities for our employees as part of a larger company. We believe that Pfizer is the ideal partner to extend the reach of our blockbuster XTANDI franchise and take our promising, late-stage assets – talazoparib and pidiluzimab – to their next stages of development so that they can be made available to patients as quickly as possible."

"The proposed acquisition of Medivation will build upon Pfizer’s success with our IBRANCE (palbociclib) launch in HR+/HER2- metastatic breast cancer and with our strong immuno-oncology portfolio, and will transform Pfizer into a leading oncology company," said Albert Bourla, group president, Pfizer Innovative Health. "IBRANCE and XTANDI are anchor brands in breast and prostate cancer respectively, giving Pfizer leadership in two hormone-driven cancers. Similar to IBRANCE in the breast cancer setting, XTANDI is being explored for its potential to move from metastatic prostate cancer to treat earlier stages of non-metastatic prostate cancer. In addition, Medivation’s portfolio within prostate cancer and across diverse tumors will complement Pfizer’s broad IO portfolio. Finally, Medivation adds commercial scale to better compete with other top tier oncology companies in advance of the potential emergence of Pfizer’s IO pipeline expected in the next few years. Together, we believe Pfizer and Medivation can bring the full force of our combined research and resources to combat two of the most common cancers, as well as speed cures and make accessible breakthrough medicines to patients, redefining life with cancer."

Cancer remains the second leading cause of death in the U.S. and a "Top 10" killer worldwide. According to the American Cancer Society, breast cancer and prostate cancer are among the top three cancers by annual incidence in the U.S. There are several parallels between breast and prostate cancer, including the incidence of prostate cancer in the U.S., which is similar to that of breast cancer with approximately 280,000 cases per year.

Pfizer expects to finance the transaction with existing cash.

Under the terms of the merger agreement, a subsidiary of Pfizer will commence a cash tender offer to purchase all of the outstanding shares of Medivation common stock for $81.50 per share, net to the seller in cash, without interest, subject to any required withholding of taxes. The closing of the tender offer is subject to customary closing conditions, including U.S. antitrust clearance and the tender of a majority of the outstanding shares of Medivation common stock. The merger agreement contemplates that Pfizer will acquire any shares of Medivation that are not tendered into the offer through a second-step merger, which will be completed promptly following the closing of the tender offer. Pfizer expects to complete the acquisition in the Third- or Fourth-Quarter 2016.

Pfizer’s financial advisors for the transaction were Guggenheim Securities and Centerview Partners, with Ropes & Gray LLP acting as its legal advisor. J.P. Morgan Securities and Evercore served as Medivation’s financial advisors, while Cooley LLP and Wachtell, Lipton, Rosen & Katz served as its legal advisors.

On August 22, 2016 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) reported financial results for the second quarter of 2016 (Press release, ImmunoCellular Therapeutics, AUG 22, 2016, View Source [SID:1234514665]).

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Andrew Gengos, ImmunoCellular Chief Executive Officer, commented: "We are pleased with the progress we made in the first half of this year, and believe that 2016 will be a year of accomplishment for our company. The first patient in the ICT-107 phase 3 trial was treated in June – a major achievement for our company. Today, more than 140 patients have been screened and clinical site activation is accelerating. We currently have activated 60 clinical sites in the US, two in Canada, and one in the UK, with more expected to come in the third quarter. With ICT-107, ImmunoCellular is one of a small number of companies in the cancer immunotherapy arena that we believe to be in the final stage of clinical development. In light of these achievements, our confidence remains high for the value and quality of our phase 3 program, and the therapeutic and commercial potential of ICT-107. The phase 1 open-label trial of ICT-121 in patients with recurrent glioblastoma has completed enrollment, reaching the target of 20 patients. The trial is being conducted at six sites in the US and preliminary results are expected in about 9 months. We are grateful for the continued support of the medical and scientific cancer community, and the confidence placed in our company by our collaborators."

Upcoming Goals and Milestones:

ICT-107:
Continue to bring US, Canadian and European clinical sites online, with the goal of having all sites in all 10 countries activated by the end of 2016.
Anticipate randomization of all patients by the end of 2017, and an additional 2-3 years from then to achieve the at least 274 required events.
Plan to conduct a futility interim analysis at 30% of events, or at about the 2-year mark, and an efficacy interim analysis at 67% of events, or at about the 2½ -year mark.
Present updated immune monitoring data from the ICT-107 phase 2 trial and updated long-term survival data from the phase 1 trial at the Society for NeuroOncology annual scientific meeting in November 2016 in two oral presentations.
ICT-121:
Continuing to monitor patients, with data expected in about 9 months.
Research:
Anticipate having one or more T cell receptors identified for a Stem-to-T-cell clinical candidate or candidates by year-end 2016.
Initial attempt to package a T cell receptor DNA sequence in the lentivirus/gene therapy construct by year-end 2016.
Continued progress in collaboration with University of Maryland on projects that have application to existing dendritic cell immunotherapy and Stem-to-T-cell technology platforms.
Second Quarter 2016 Financial Results

For the quarter ended June 30, 2016, ImmunoCellular incurred a net loss of $5.3 million, or $0.06 per basic and diluted share, compared to a net loss of $3.2 million, or $0.03 per basic and diluted share, for the quarter ended June 30, 2015.

During the second quarter 2016, ImmunoCellular incurred $4.4 million of research and development expenses compared to $2.3 million in the prior year quarter while general and administrative expenses remained relatively constant between periods. The $2.1 million increase in research and development expenses primarily reflects the additional expenses associated with the phase 3 trial of ICT-107.

For the six months ended June 30, 2016, ImmunoCellular incurred a net loss of $11.0 million, or $0.12 per basic and diluted share, compared to a net loss of $4.6 million, or $0.05 per basic and diluted share, During the six months ended June 30, 2016, ImmunoCellular incurred $9.2 million in research and development expenses compared to $4.4 million in the prior year.

ImmunoCellular also reported that cash used in operations during the six months ended June 30, 2016 was $11.2 million compared to $6.9 million in the prior year. The increase primarily reflects that additional research and development expenditures in the current year. As of June 30, 2016, ImmunoCellular had $11.9 million in cash.

Subsequent to June 30, 2016, ImmunoCellular entered into an underwriting agreement with Maxim Group LLC, pursuant to which it sold 34,550,000 shares of common stock, pre-funded warrants to purchase 12,450,000 shares of ImmunoCellular’s common stock and base warrants to purchase 35,250,000 shares of its common stock. The common stock and base warrants were sold at a combined public offering price of $0.16, and the base warrants were approved for listing on the NYSE MKT under the symbol "IMUC.WS." The pre-funded warrants were sold to certain investors in lieu of common stock less the $0.01 per share exercise price for each pre-funded warrant. The base warrants have an exercise price of $0.1921 per share. Additionally, ImmunoCellular granted the underwriters a 45 day option to purchase up to an additional 7,050,000 shares of common stock and/or base warrants to purchase 5,287,000 shares of its common stock. On August 12, 2016, the underwriters exercised the option to purchase 4,478,625 of additional base warrants at a price of $0.01266 per base warrant. The gross proceeds from the offering are approximately $7.5 million.

Additionally, the terms of the California Institute of Regenerative Medicine (CIRM) award were modified such that ImmunoCellular received an additional $1.5 million in July 2016 as part of the initial award received from CIRM. The total amount of the award and other award conditions remain unchanged.