On October 30, 2019 Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, reported recent tazemetostat program updates, including successfully completing a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) for its tazemetostat program for follicular lymphoma (FL), G9a program updates and third quarter 2019 financial results (Press release, Epizyme, OCT 30, 2019, View Source [SID1234550014]).

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"We are very pleased with the outcome of our recent pre-NDA meeting and the continued alignment with FDA on our registration strategy for FL patients, regardless of their EZH2 status, who have received at least two prior systemic therapies," said Dr. Shefali Agarwal, chief medical officer of Epizyme. "FL remains an incurable disease, and we believe strongly in the potential of tazemetostat to make a difference for these patients. We are on track to submit our FL NDA for accelerated approval in December and look forward to continuing to engage with FDA as we work to bring tazemetostat to both FL and epithelioid sarcoma patients in the U.S. next year."

Tazemetostat Program Updates

Pre-NDA Meeting Supports Planned NDA Submission for FL: During a recent pre-NDA meeting, Epizyme gained alignment with the FDA that the proposed data package is sufficient to support a submission for accelerated approval of tazemetostat as a monotherapy for relapsed or refractory FL patients, both with EZH2 activating mutations and wild-type EZH2, who have received at least two prior systemic therapies. Epizyme is on track to submit the NDA for this indication in December 2019.

Mature Phase 2 Data to be Reported in Oral Presentation at ASH (Free ASH Whitepaper): Epizyme’s abstract on data from its ongoing Phase 2 trial in FL as of a June 7, 2019 data cutoff has been selected for an oral presentation on Saturday, Dec. 7 at the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Updated data, as assessed by both investigators and independent reviewers from a later data cutoff than the abstract submission, will be presented and will serve as the basis for the planned FL NDA submission.

Gained Alignment with FDA on Single Confirmatory Trial for FL: Epizyme gained alignment with FDA on a single confirmatory trial to support a submission for full approval. This global, randomized, adaptive trial will evaluate the combination of tazemetostat with "R2" (Revlimid plus Rituxan), an approved chemo-free treatment regimen, for FL patients in the second-line or later treatment setting. The trial is expected to enroll approximately 500 FL patients, stratified based on their EZH2 mutation status. Site initiation is underway and the safety run-in portion of the trial is on track to begin in the fourth quarter of 2019.

Preparing for Epithelioid Sarcoma (ES) U.S. Commercial Launch with Jan. 23, 2020 PDUFA Date: Priority Review was granted by FDA for Epizyme’s NDA for accelerated approval of tazemetostat for patients with metastatic or locally advanced ES who are not eligible for curative surgery. To support a potential early 2020 approval and launch, the company’s go-to-market strategy has been finalized. An experienced commercial and medical affairs team is now in place to expand the knowledge and awareness of ES among the treating and patient communities and ensure seamless patient access to tazemetostat, if approved.

ES Confirmatory Trial Ready to Begin in Fourth Quarter: Epizyme has begun initiating sites for its confirmatory trial to support a submission for full approval of tazemetostat for ES. This global, randomized, controlled trial will assess the combination of tazemetostat plus doxorubicin, a commonly used systemic treatment, compared with doxorubicin alone as a front-line treatment. The trial is expected to enroll approximately 150 patients, with the safety run-in portion to begin in the fourth quarter of 2019.

Combination Trial Open for Castration-Resistant Prostate Cancer (CRPC): Epizyme is conducting a Phase 1b/2 clinical trial in chemo-naïve patients with metastatic CRPC, assessing tazemetostat with enzalutamide or with abiraterone, the standard-of-care treatments for this patient population. Epizyme recently presented preclinical data at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference on Molecular Targets, which demonstrated that tazemetostat in combination with an androgen signaling inhibitor (ASI) increased tumor growth inhibition more than either agent alone. Site initiation is underway and the dose-escalation Phase 1b portion of the trial is on track to begin in the fourth quarter of 2019.

G9a Program Update

Epizyme has decided to refocus its preclinical program targeting G9a on other potential development candidates and discontinue development of EZM-8266. This decision was made after a review of development path implications of a preclinical toxicology finding of EZM-8266. The company is evaluating next steps for its G9a program to develop an oral, disease-modifying approach to treating a variety of hemoglobinopathies, including sickle cell disease.

Leadership Team Expansion

Epizyme further strengthened its management team with the appointment of Mark De Rosch, Ph.D., to chief regulatory officer. Dr. De Rosch joined Epizyme from Nightstar Therapeutics, where he served as senior vice president, regulatory affairs and quality assurance, and brings more than 25 years of global regulatory strategy and operations experience, including having successfully led the regulatory strategy and marketing approval of KalydecoTM, the first disease-modifying treatment for people with cystic fibrosis when at Vertex Pharmaceuticals. Dr. De Rosch earned a B.S. in chemistry/biochemistry from the University of Wisconsin, and an M.S. and Ph.D. in inorganic chemistry from the University of California, San Diego.

"Over the course of 2019, we’ve made significant progress building out critical functions, advancing and expanding tazemetostat development, and continuing our evolution toward becoming a commercial company," said Robert Bazemore, president and chief executive officer of Epizyme. "I am proud of what we have achieved thus far, with much more to come in the next several months. We have multiple trials to initiate, a second NDA to submit and a first U.S. commercial launch to execute, if approved. We are thrilled to be on the cusp of delivering tazemetostat to patients and look forward to continued progress."

Third Quarter 2019 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $292.9 million as of Sept. 30, 2019.

Revenue: Collaboration revenue for the third quarter of 2019 was $5.7 million, compared to no revenue for the third quarter of 2018. This collaboration revenue was earned as part of the Company’s Boehringer Ingelheim collaboration, which includes a $1.25 million quarterly installment in connection with the Company’s research activities.

R&D Expenses: Research and development (R&D) expenses were $26.6 million for the third quarter of 2019, compared to $27.0 million for the third quarter of 2018. The decrease primarily relates to decreases in clinical trial expenses and tazemetostat manufacturing costs, offset by an increase in discovery research activities related to tazemetostat in other indications.

G&A Expenses: General and administrative (G&A) expenses were $17.1 million for the third quarter of 2019, compared to $11.5 million for the third quarter of 2018. The increase is due primarily to pre-commercialization activities and staffing, as well as increased personnel related expenses.

Net Loss Attributed to Common Stockholders: Net loss attributable to common stockholders was $36.1 million, or $0.40 per share, for the third quarter of 2019, compared to $37.5 million, or $0.54 per share, for the third quarter of 2018.

Financial Guidance

Based on its current operating plan, Epizyme continues to expect its cash runway to extend into the first quarter of 2021.

On October 30, 2019 GSK reported sales of £9.4 billion +16% AER, +11% CER (Pro-forma +6% CER*) (Press release, GlaxoSmithKline, OCT 30, 2019, View Source [SID1234550037]).

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Financial highlights
Reported Group sales £9.4 billion +16% AER, +11% CER (Pro-forma growth +6% CER*); Pharmaceuticals £4.5 billion +7% AER, +3% CER; Vaccines £2.3 billion +20% AER, +15% CER; Consumer Healthcare
£2.5 billion +30% AER, +25% CER (Pro-forma growth +3% CER*)
Total Group operating margin 22.9%; Adjusted Group operating margin 29.7% reflecting increased spending on R&D and priority assets, and the impact of generic Advair in the US, partly offset by Vaccines performance (Pharmaceuticals 24.1%; Vaccines 50.3%; Consumer Healthcare 24.3%)
Total EPS 31.4p +9% AER, -1% CER, Adjusted EPS 38.6p +9% AER, +1% CER reflecting operating performance and lower effective tax rate offset by increased profit allocation to non-controlling interests
9 months net cash flow from operations £4.6 billion. Free cash flow £2.5 billion
19p dividend declared for the quarter, continue to expect 80p for FY19
Consumer Healthcare JV with Pfizer completed 31 July creating new world leader in Consumer Healthcare
2019 Adjusted EPS guidance improved to expectation of around flat at CER from a decline of -3% to -5%
Product and pipeline highlights
Shingrix sales £535 million +87% AER, +76% CER driven by continuing strong execution in the US
Total Respiratory sales £806 million +25% AER, +19% CER. Nucala £203 million +40% AER, +33% CER
Trelegy £139 million +>100% AER, +>100% CER
Total HIV sales £1.3 billion, +5% AER, flat at CER. Two-drug regimen sales £119 million
Continued progress to strengthen and advance R&D pipeline including:
Oncology:

Positive data presented at ESMO (Free ESMO Whitepaper) from PRIMA trial of Zejula monotherapy showing significant improvement in PFS in women with ovarian cancer regardless of biomarker status. On track to file by end 2019
Positive headline data from pivotal DREAMM-2 study of belantamab mafodotin (GSK2857916) for multiple myeloma. On track to file by end 2019
Positive data from GARNET study of dostarlimab for advanced or recurrent endometrial cancer. On track to file by end 2019
Positive data presented at ESMO (Free ESMO Whitepaper) on GSK3359609 (ICOS receptor agonist) plus pembrolizumab in head and neck squamous cell carcinoma. Phase II/III registrational trial announced
Respiratory:

Nucala approved in EU for self-administration by patients with severe eosinophilic asthma
Trelegy Ellipta submitted to the FDA for use in patients with asthma
HIV:

Long-acting injectable cabotegravir + rilpivirine submitted to EMA as the first monthly treatment for HIV
Positive phase III results from ATLAS-2M study of cabotegravir + rilpivirine administered every 8 weeks
Other:

Phase III start for first-in-class antibiotic, gepotidacin, in uncomplicated urinary tract infection and urogenital gonorrhoea
Daprodustat filed in Japan for patients with renal anaemia due to chronic kidney disease

Emma Walmsley, Chief Executive Officer, GSK said:
"GSK has made further good progress in Q3, with sales growth across all three businesses, and we have today upgraded our full-year EPS guidance. This quarter we have continued to strengthen our pipeline and have advanced assets in Respiratory, HIV and, notably, Oncology, where we are on track to file three innovative medicines by year end, following positive pivotal trial data. We also achieved a significant milestone with the completion of our new Consumer Healthcare Joint Venture with Pfizer, to create a new world leading consumer healthcare business."

On October 30, 2019 NantHealth, Inc. (NASDAQ-GS: NH), a next-generation, evidence-based, personalized healthcare company, reported that it will report financial results for its 2019 third quarter on Thursday, November 7, 2019, after market close (Press release, NantHealth, OCT 30, 2019, View Source [SID1234550053]). NantHealth management will host a conference call that same day at 1:30 p.m. PT (4:30 p.m. ET) to review the company’s performance.

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The conference call will be available to interested parties by dialing 844-309-3709 from the U.S. or Canada, or 281-962-4864 from international locations, passcode 3294717. The call will be broadcast via the Internet at www.nanthealth.com.

On October 30, 2019 LUNGevity Foundation, the nation’s leading lung cancer-focused nonprofit organization, reported the launch of the #ChangeLungCancer social media campaign (Press release, LUNGevity Foundation, OCT 30, 2019, View Source [SID1234550069]). LUNGevity is proud to provide a new way for lung cancer advocates to get involved this November during Lung Cancer Awareness Month through this social media campaign.

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The campaign will raise awareness of lung cancer and help inspire others to help drive change through a variety of downloadable signs with powerful messages. Participants simply take a selfie holding one of several #ChangeLungCancer signs and share it on social media with their personal reason for changing lung cancer.

"Each year during Lung Cancer Awareness Month, we try to equip individuals with the tools they need to help spread awareness about lung cancer," Andrea Ferris, President and CEO of LUNGevity, said. "We know our community is very active on social media, and we are incredibly excited about the potential to raise awareness and drive change through this new vehicle. Together we can have the greatest impact on this disease."

Follow LUNGevity on social media to see stories of the #ChangeLungCancer campaign participants. Among them are patients/survivors, including members of ALK Positive, EGFR Resisters, and RET Renegades; doctors, including Raja Flores from Mount Sinai and Drew Moghanaki from Atlanta VA Medical Center and Emory Winship Cancer Institute; and researchers, including the members of LUNGevity’s newest class of Career Development Awardees, among others.

Choose your favorite sign and download it at www.LUNGevity.org/LCAMsigns.

Throughout November, LUNGevity provides many ways to get involved for Lung Cancer Awareness Month. LUNGevity believes strongly that everyone can drive progress and change for people affected by the disease, and invites its constituents to get involved, whether through social media advocacy, distributing educational materials, attending a Breathe Deep event, or organizing events and activities to raise funds and awareness.

On October 30, 2019 Bristol-Myers Squibb Company (NYSE:BMY) ("Bristol-Myers Squibb") reported the extension of the expiration date of the offers to exchange (the "Exchange Offers") notes (the "Celgene Notes") issued by Celgene Corporation (NASDAQ:CELG) ("Celgene") for up to $19,850,000,000 aggregate principal amount of new notes to be issued by Bristol-Myers Squibb Company (the "Bristol-Myers Squibb Notes") and cash and the related consent solicitations (the "Consent Solicitations") being made by Bristol-Myers Squibb on behalf of Celgene to adopt certain proposed amendments (the "Amendments") to the indentures governing the Celgene Notes (Press release, Bristol-Myers Squibb, OCT 30, 2019, View Source;3 [SID1234550015]). Bristol-Myers Squibb hereby extends such expiration date from 5:00 p.m., New York City time, on October 31, 2019, to 5:00 p.m., New York City time, on November 4, 2019 (as the same may be further extended, the "Expiration Date").

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On the early participation date of May 1, 2019, requisite consents were received and supplemental indentures were executed, eliminating substantially all restrictive covenants and certain events of default and other provisions in each of the indentures governing the Celgene Notes. Such supplemental indentures will only become operative upon the settlement date of the Exchange Offers.

The Exchange Offers and Consent Solicitations are being made pursuant to the terms and subject to the conditions set forth in the confidential offering memorandum and consent solicitation statement dated April 17, 2019 and the related letter of transmittal hereby, each as amended by the press releases dated May 1, 2019, May 24, 2019, June 28, 2019, September 23, 2019, October 8, 2019, October 18, 2019 and as amended hereby, and are conditioned upon the closing of Bristol-Myers Squibb’s acquisition of Celgene (the "Merger"), which condition may not be waived by Bristol-Myers Squibb, and certain other conditions that may be waived by Bristol-Myers Squibb.

The settlement date for the Exchange Offers is expected to occur promptly after the Expiration Date and on or about the closing date of the Merger. The closing of the Merger is expected to occur by the end of 2019. As a result, the Expiration Date may be further extended one or more times. Bristol-Myers Squibb will provide notice of any such extension in advance of the Expiration Date.

Except as described in this press release, all other terms of the Exchange Offers and Consent Solicitations remain unchanged.

As of 5:00 p.m., New York City time, on October 29, 2019, the principal amounts of Celgene Notes set forth in the table below had been validly tendered and not validly withdrawn:

Documents relating to the Exchange Offers and Consent Solicitations will only be distributed to eligible holders of Celgene Notes who complete and return an eligibility form confirming that they are either a "qualified institutional buyer" under Rule 144A or not a "U.S. person" and outside the United States under Regulation S for purposes of applicable securities laws. Except as amended by the press releases dated May 1, 2019, May 24, 2019, June 28, 2019, September 23, 2019, October 8, 2019, October 18, 2019 and as amended hereby, the complete terms and conditions of the Exchange Offers and Consent Solicitations are described in the confidential offering memorandum and consent solicitation statement dated April 17, 2019 and the related letter of transmittal, copies of which may be obtained by contacting Global Bondholder Services Corporation, the exchange agent and information agent in connection with the Exchange Offers and Consent Solicitations, at (866) 470 3900 (U.S. toll-free) or (212) 430 3774 (banks and brokers). The eligibility form is available electronically at: View Source