On May 10, 2022 Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reportd that it is hosting an R&D Symposium today in New York City (Press release, Corvus Pharmaceuticals, MAY 10, 2022, View Source [SID1234614101]). During the event, which will also be available via webcast, the Company plans to provide updates on its three clinical programs: mupadolimab (anti-CD73), ciforadenant (adenosine 2A receptor antagonist) and CPI-818 (ITK inhibitor) .

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"Current therapies for T cell lymphoma have limited efficacy, highlighting the need for new approaches that rely on novel mechanisms of action," said Neel K. Gupta, M.D., Clinical Assistant Professor of Medicine at Stanford University School of Medicine – Division of Oncology. "The monotherapy activity and responses in advanced refractory T cell lymphoma seen with the ITK inhibitor CPI-818 so far is impressive. Its novel mechanism of action and safety provide many opportunities for single agent and combination with other therapies both in front line and relapsed disease settings, giving CPI-818 the potential to be an important new therapeutic option for T cell lymphoma patients."

New CPI-818 Phase 1/1b Data
The R&D Symposium will include a review of patient case studies from the ongoing Phase 1/1b clinical trial of CPI-818 in patients with relapsed T cell lymphomas, including peripheral T cell lymphoma (PTCL), cutaneous T cell lymphoma (CTCL), angioimmunoblastic T cell lymphoma (AITL) and others. In this trial, which was designed to select the optimal dose of CPI-818, doses of 100, 200, 400 and 600 mg taken twice a day were given to successive cohorts of patients. The 200 mg dose was identified as the optimal dose, and at this dose, four of five patients are responding to therapy as follows (with an April 30, 2022 cut-off date):

PTCL patient achieved a complete response lasting 12 months on CPI-818 treatment with complete remission duration extending an additional 7 months with no further therapy (total complete remission duration of 19 months)
PTCL patient achieved a partial response with treatment ongoing
AITL patient that is responding on treatment
CTCL patient achieved nodal complete response with treatment lasting 21 months
In addition, a PTCL patient receiving the 600 mg dose achieved a partial response that lasted for several months; the patient went on to receive a bone marrow transplant
Lab studies on the blood and tumors of responding patients showed:
Evidence for Th1 skewing
Evidence for increase in T effector cells in blood and tumor
Evidence for increase activation of T cells in tumor and blood
Evidence that CPI-818 does not directly kill the cancer cells; rather the effects appear to be mediated by the patient’s immune response against the tumor
Identification of a dose level that drives Th1 cell differentiation without compromising T effector cell function
CPI-818 is a novel compound that Corvus founders invented and developed based on their prior experience and success with the first BTK inhibitor, ibrutinib.

"We have learned a tremendous amount about ITK, T cell biology and potential indications for this therapy from the development of CPI-818," said Richard A. Miller, M.D., Chief Executive Officer & President of Corvus Pharmaceuticals. "The new interim data from our Phase 1/1b study are consistent with our pre-clinical results, and the research of others, which reveal the role of ITK in T cell function, and the exquisite regulation of T cell differentiation by ITK. Based on this, we believe CPI-818 could be used to enhance anti-tumor immunity in T cell lymphoma and solid tumors by stimulating anti-tumor T cells to attack the cancer cells. The mechanism, and preclinical data, also support its role in immune mediated diseases such as allergy and autoimmunity."

"We are expanding our CPI-818 Phase 1/1b study with a focus on the 200 mg BID dose in PTCL. Angel Pharmaceuticals, our Chinese partner, is also enrolling patients, which we anticipate will help accelerate overall development timelines. Our goal is to share additional data from both studies later this year, and if current trends continue, we anticipate initiating a global Phase 2 clinical trial. We will also be evaluating CPI-818’s potential in front line combination therapy with chemotherapy and preparing for clinical studies in autoimmune diseases," added Dr. Miller.

Corvus R&D Pipeline Approach
The R&D Symposium program will cover the scientific rationale, preclinical and clinical data for the Company’s three programs, along with the overarching scientific and clinical strategies driving the Company’s development activities. Key elements of the overarching strategy include:

Corvus’ precision immunotherapy approach focuses on controlling multiple steps in the "tumor-immunity axis," which is comprised of the tumor, lymph nodes (LN) and blood stream. The Company’s product candidates are designed to modulate tumor immunity, target precise molecular structures and have broad clinical applications. Specifically, mupadolimab, ciforadenant, and CPI-818 all interact with distinct and connected components of the tumor-immunity axis to enhance immunity to cancers:
Mupadolimab is designed to induce the activation of B cells involved in antibody production, and antigen presentation in the tumor, blood and in LN
Ciforadenant is designed to block adenosine-induced immunosuppression in tumors and in LN
CPI-818 is designed to induce the activation and expansion of T cell subsets involved in killing cancer cells in tumor, in LN and in blood through the skewing of T cell differentiation to a Th1 helper T cell phenotype. The formation of Th1 cells leads to production of T cells that are capable of killing cancer cells and viral infected cells
Corvus’ clinical development strategy aims to increase clinical development success by first establishing monotherapy activity, followed by potential combinations with other immuno-oncology and standard of care therapies
R&D Symposium Details
The R&D symposium will be webcast live from Corvus’s website at www.corvuspharma.com and a replay will be available for 90 days following the event. A copy of the presentation slides will also be available on Corvus’ website after the conclusion of the event. It will be hosted by Corvus President and CEO Richard A. Miller, M.D., and include speakers from Corvus as well as leading researchers:

Neel K. Gupta, M.D., Clinical Assistant Professor of Medicine at Stanford University School of Medicine – Division of Oncology
Suresh Mahabhashyam, M.D., Vice President of Clinical Development at Corvus Pharmaceuticals
Erik Verner, Ph.D., Senior Vice President of Research at Angel Pharmaceuticals

On May 10, 2022 PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, reported financial results for the first quarter ended March 31, 2022, and provided a corporate update (Press release, PMV Pharma, MAY 10, 2022, View Source [SID1234614100]).

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"Our priority in 2022 is execution of the ongoing Phase 1/2 trial evaluating PC14586, our investigational first-in-class p53 Y220C reactivator, in patients with solid tumors, as well as continued progress on our pipeline" said David Mack, Ph.D., President, and Chief Executive Officer. "We look forward to presenting initial data from the Phase 1 dose escalation trial at the 2022 ASCO (Free ASCO Whitepaper) annual meeting."

Corporate Highlights:

PC14586 initial data from the dose escalation portion of the Phase 1/2 PYNNACLE study selected for an oral presentation at the 2022 ASCO (Free ASCO Whitepaper) annual meeting on June 7th. For more information on the Phase 1/2 trial, refer to www.clinicaltrials.gov (NCT study identifier NCT04585750).
Poster titled "Small Molecule Reactivators of Y220C Mutant p53 Modulate Tumor Infiltrating Leukocytes and Synergize with Immune Checkpoint Inhibitors" presented at the American Association of Cancer Research Annual Meeting 2022.
Continued progress on research pipeline with WIP1 (Wild-Type p53-Induced Phosphatase) inhibitor and p53 mutant programs.
First Quarter 2022 Financial Results

As of March 31, 2022, PMV Pharma had $294.8 million in cash, cash equivalents, and marketable securities, compared to $314.1 million as of December 31, 2021. Net cash used in operations was $18.0 million for the three months ended March 31, 2022 compared to $12.9 million for the three months ended March 31, 2021.
Net loss for the quarter ended March 31, 2022 was $18.4 million compared to $11.6 million for the quarter ended March 31, 2021.
Research and development (R&D) expenses were $11.8 million for the quarter ended March 31, 2022 compared to $7.5 million for the quarter ended March 31, 2021. The increase in R&D expenses was primarily related to increased headcount and clinical development expenses to advance PC14586, the Company’s lead drug candidate.
General and administrative (G&A) expenses were $6.8 million for the quarter ended March 31, 2022, compared to $4.2 million for the quarter ended March 31, 2021. The increase in G&A expenses was primarily due to expanding the infrastructure necessary for operating as a public company.
About PC14586

PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the crevice present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor-suppressing function. PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. For more information on the Phase 1/2 PYNNACLE trial (PMV-586-101), refer to www.clinicaltrials.gov (NCT study identifier NCT04585750).

On May 10, 2022 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported its financial results for the first quarter of 2022 and provided a corporate update (Press release, Aclaris Therapeutics, MAY 10, 2022, View Source [SID1234614099]).

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"We have continued to progress our clinical programs, including activating multiple clinical sites in our Phase 2b trial of ATI-1777 in subjects with moderate to severe atopic dermatitis," said Dr. Neal Walker, President and CEO of Aclaris. "We look forward to advancing all of our clinical and preclinical programs."

Research and Development Highlights:

Clinical Programs

Zunsemetinib, an investigational oral small molecule MK2 inhibitor:
Currently being developed as a potential treatment for immuno-inflammatory diseases

ATI-450-RA-202: This Phase 2b dose ranging trial to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses (20 mg and 50 mg twice daily) of zunsemetinib in combination with methotrexate in subjects with moderate to severe rheumatoid arthritis (RA) is ongoing.
Aclaris expects topline data in 2023.

ATI-450-HS-201: This Phase 2a trial to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of zunsemetinib (50 mg twice daily) in subjects with moderate to severe hidradenitis suppurativa (HS) is ongoing.
Aclaris expects topline data in the first half of 2023.

ATI-450-PsA-201: Aclaris expects to activate clinical sites in the coming weeks in this Phase 2a trial of zunsemetinib (50 mg twice daily) in subjects with moderate to severe psoriatic arthritis.
ATI-1777, an investigational topical "soft" Janus kinase (JAK) 1/3 inhibitor:
Currently being developing as a potential treatment for moderate to severe atopic dermatitis (AD)

ATI-1777-AD-202: Aclaris activated multiple clinical sites in May 2022 in this Phase 2b trial to determine the efficacy, safety, tolerability and pharmacokinetics of ATI-1777 in subjects with moderate to severe AD. In this trial, Aclaris will explore multiple concentrations of twice daily treatment with ATI-1777 and a single concentration of once daily treatment with ATI-1777, in patients 12 years and older.
Aclaris expects topline data in the first half of 2023.
ATI-2138, an investigational oral ITK/TXK/JAK3 (ITJ) inhibitor:
Currently being developed as a potential treatment for T cell-mediated autoimmune diseases

ATI-2138-PKPD-101: This Phase 1 single ascending dose (SAD) trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-2138 in healthy subjects is ongoing.
Aclaris expects topline data in 2022.

If the Phase 1 SAD trial is successful, Aclaris currently plans to initiate a two-week Phase 1 multiple ascending dose trial of ATI-2138 in subjects with psoriasis in 2022. Aclaris is also currently exploring alternative indications to the planned indication that are relevant to the mechanism of action.
Preclinical Programs

ATI-2231, an investigational oral MK2 inhibitor compound:
Currently being explored as a potential treatment for pancreatic cancer and metastatic breast cancer as well as in preventing bone loss in patients with metastatic breast cancer

Second MK2 inhibitor generated from Aclaris’ proprietary KINect drug discovery platform and designed to have a long half-life.

IND-enabling studies are underway, and Aclaris expects to submit an IND by the end of 2022.
Discovery Programs

Currently developing oral gut-biased JAK inhibitors with limited systemic exposure as potential treatments for inflammatory bowel disease.
Central nervous system (CNS) kinase inhibitor targets:
Currently engaged in research to identify brain penetrant kinase inhibitor candidates and assess their impact on neuronal pro-inflammatory cytokine production, microglia growth and survival, and neurodegeneration.
Other Highlights

Aclaris continues to expand its senior R&D team and recently appointed Ian Anderson, Ph.D., as Executive Vice President, Translational Research & Development, and Rob Ortmann, M.D., as Vice President, Clinical Development. Dr. Anderson brings more than 30 years of immunology research experience in drug development, from discovery through Phase 2. He previously held senior scientific leadership roles at Flame Biosciences, Janssen Pharmaceutical, MedImmune and Cambridge Antibody Technology. Dr. Ortmann is a board-certified rheumatologist with more than 10 years of clinical research experience in autoimmune-related therapeutic areas. He previously held clinical development positions at Horizon Therapeutics and Eli Lilly and Company.

Financial Highlights:

Liquidity and Capital Resources

As of March 31, 2022, Aclaris had aggregate cash, cash equivalents and marketable securities of $204 million compared to $226 million as of December 31, 2021. Additionally, in April 2022, Aclaris sold approximately 4.8 million shares under its ATM facility for aggregate net proceeds of $73 million.

Aclaris now anticipates that its cash, cash equivalents and marketable securities as of March 31, 2022 in combination with the $73 million in net proceeds from the April 2022 ATM sale will be sufficient to fund its operations through the end of 2025, without giving effect to any additional potential business development transactions or financing activities.

Financial Results

First Quarter 2022

Net loss was $18.8 million for the first quarter of 2022 compared to $28.8 million for the first quarter of 2021.
Total revenue was $1.5 million for the first quarter of 2022 compared to $1.8 million for the first quarter of 2021.
Research and development (R&D) expenses were $14.3 million for the quarter ended March 31, 2022 compared to $7.8 million for the prior year period.
The $6.5 million increase was primarily the result of:
Higher zunsemetinib development expenses, including costs associated with clinical activities for a Phase 2b trial for RA and a Phase 2a trial for HS.
Higher ATI-1777 development expenses related to drug candidate manufacturing and other preclinical activities and start-up costs associated with a Phase 2b clinical trial.
Higher preclinical development activities related to ATI-2231.

General and administrative (G&A) expenses were $6.1 million for the quarter ended March 31, 2022 compared to $4.8 million for the prior year period.
The $1.3 million increase was primarily the result of higher compensation-related costs, including stock-based compensation, due to increased headcount and the impact of new equity awards granted during the first quarter of 2022.
Revaluation of contingent consideration resulted in a $1.2 million credit for the quarter ended March 31, 2022 compared to a contingent consideration charge of $16.4 million for the prior year period.

On May 10, 2022 Epizyme (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering transformative therapies for cancer patients against novel epigenetic targets, reported first quarter 2022 financial results and provided a business update (Press release, Epizyme, MAY 10, 2022, View Source [SID1234614098]).

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"The relapsed or refractory follicular lymphoma treatment landscape is rapidly changing, and we believe TAZVERIK is poised to grow at an accelerated rate as the year progresses. We saw encouraging progress in important commercial metrics during the first quarter despite some seasonal impact related in part to the Medicare Part D drug benefit design and year-end prescription variability, which we continue to evaluate. TAZVERIK demand experienced a strong rebound in March, and we entered the second quarter with positive momentum. We believe that TAZVERIK has the potential to reach many more patients based on changes in the current treatment options for patients in the R/R FL market and the updated NCCN Guidelines for FL," said Grant Bogle, President and Chief Executive Officer. "We are also continuing to advance our key clinical programs and look forward to sharing updated SYMPHONY-1 data from the Phase 1b cohort at ASCO (Free ASCO Whitepaper)."

Recent Progress

TAZVERIK (tazemetostat) commercial progress:

TAZVERIK generated net product revenue of $8.7 million for the first quarter of 2022, including $0.5 million related to the sale of TAZVERIK commercial product for third-party pharmaceutical company use in clinical trials. TAZVERIK commercial net sales in the first quarter of 2022 were $8.1 million, representing an increase of approximately 10% when compared to $7.4 million in the fourth quarter of 2021.

Commercial demand increased 16% in the first quarter of 2022 versus the fourth quarter of 2021 levels while total demand (commercial demand and free goods supplied through the patient assistance program) in the first quarter of 2022 was similar to fourth quarter 2021 levels. The Company believes the difference in total demand as compared with commercial demand was related, in part, to limitations of the Medicare Part D drug benefit design and year-end prescription variability, which followed a similar pattern in 2021. While total demand was soft in the beginning of the quarter, it rebounded in March to its highest monthly level since launch. Additional time is needed to fully evaluate and understand seasonality and fluctuations.

Recent market research suggests that TAZVERIK market share continues to grow in the third-line setting for both EZH2 mutation-positive and wild-type populations, consistent with the Company’s commercial focus and messaging. The amount of free goods supplied to patients through Epizyme’s patient assistance program represented approximately 15% of total demand for the first quarter of 2022. This rate was consistent with the first quarter of 2021.

National Comprehensive Cancer Network (NCCN) released updated NCCN Guidelines for B-Cell Lymphomas: The recently updated NCCN Guidelines for grade 1-2 follicular lymphoma (FL) now include tazemetostat as a suggested treatment regimen in the second line for elderly or infirm patients with EZH2 wild type or unknown relapsed/refractory (R/R) disease in patients who have no satisfactory alternative treatment options. For third-line and subsequent therapy, tazemetostat is a suggested treatment regimen for patients with EZH2 mutation-positive disease or patients with EZH2 wild-type or unknown R/R disease who have no satisfactory alternative treatment options.

Global enrollment open and actively screening in the randomized Phase 3 portion of SYMPHONY-1 (EZH-302): Dosing of the first patient was recently completed in the Phase 3 portion of the SYMPHONY-1 study, and the study is open globally and is actively screening and enrolling patients. SYMPHONY-1 is the confirmatory study assessing tazemetostat in combination with rituximab + lenalidomide (R2) compared with R2 plus placebo in patients with R/R FL previously treated with at least one systemic therapy, including those who are rituximab-refractory and/or have experienced progression of disease within two years (POD24). Updated data from the Phase 1b portion of SYMPHONY-1 was accepted for a poster presentation, which will be shared at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago from June 3-7. Data to be presented include updated overall response rate and complete response rate data as well as a subgroup analysis of rituximab-refractory and POD24 patients. The Company continues to follow this Phase 1b cohort of patients and plans to present additional updated data later this year.

LYSA Phase 2 study enrollment nearly complete; top-line results expected in second half of 2022: Enrollment in the FL arm is complete for the Phase 2 portion of the Lymphoma Study Association (LYSA) study, a Phase 1b/2 combination study of tazemetostat with R-CHOP in high-risk, front-line FL and diffuse large B-cell lymphoma (DLBCL) patients. Epizyme, in collaboration with LYSA, anticipates presenting top-line results from the Phase 2 portion of the study in the second half of 2022.

CELLO-1 Phase 2 study 85% enrolled; updated safety run-in data and interim data from the Phase 2 portion of the study expected in second half of 2022: The Phase 2 portion of the CELLO-1 study (EZH-1101), which is evaluating tazemetostat plus enzalutamide compared to enzalutamide monotherapy in metastatic castration-resistant prostate cancer patients, is approximately 85% enrolled toward a target of 80 patients. In 2022, Epizyme expects to complete enrollment in the randomized Phase 2 portion of the study and present updated data from the safety run-in portion as well as interim safety and efficacy data from the Phase 2 portion of the study in the second half of the year.

We continue to screen patients in ARIA (EZH-1501), the Phase 1b/2 tazemetostat hematological basket study, and SET-101, the Phase 1/1b study of EZM0414. Epizyme plans to provide updates on these programs in the second half of 2022.

First Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $199.7 million as of March 31, 2022, compared to $176.8 million as of December 31, 2021.

Revenue: Total revenue was $8.7 million for the first quarter of 2022, an increase of 14% vs. $7.6 million for the first quarter of 2021. Net product revenue of TAZVERIK in the U.S was $8.7 million for the first quarter of 2022, an increase of 40% vs. $6.2 million for the first quarter of 2021.

Operating Expenses: Total GAAP operating expenses were $59.6 million for the first quarter of 2022, a decrease of 17% vs. $72.0 million for the first quarter of 2021, reflecting focused efforts on streamlining operations. Total non-GAAP adjusted operating expenses were $53.0 million for the first quarter of 2022, compared to $63.7 million for the first quarter of 2021.

R&D expenses: GAAP R&D expenses were $29.8 million for the first quarter of 2022, compared to $32.7 million for the first quarter of 2021. Non-GAAP adjusted R&D expenses were $27.8 million for the first quarter of 2022, compared to $30.3 million for the first quarter of 2021.

SG&A expenses: GAAP SG&A expenses were $27.2 million for the first quarter of 2022, compared to $36.4 million for the first quarter of 2021, representing a 25% decrease following the previously announced operating expense and workforce reductions. Non-GAAP adjusted SG&A expenses were $23.6 million for the first quarter of 2022, compared to $31.5 million for the first quarter of 2021.

Net Loss (GAAP): Net loss attributable to common stockholders was $55.5 million, or $0.38 per share, for the first quarter of 2022, compared to $70.3 million, or $0.69 per share, for the first quarter of 2021.

A reconciliation of non-GAAP adjusted financial measures directly comparable to GAAP financial measures is presented in the table attached to this press release.

Conference Call Information

Epizyme will host a conference call today, May 10, at 8:30 a.m. ET. To participate, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 5369344. A webcast, as well as supplemental slides to support the webcast, will be available in the investor section of the Company’s website at www.epizyme.com, and will be archived for 60 days following the call.

About Non-GAAP Financial Measures

In addition to financial information prepared in accordance with the U.S. generally accepted accounting principles (GAAP), this press release includes the following non-GAAP financial measures: total non-GAAP adjusted operating expenses on a historical basis, non-GAAP adjusted R&D expenses on a historical basis and non-GAAP adjusted SG&A expenses on a historical basis. Epizyme derives these non-GAAP financial measures by excluding certain expenses and other items from the respective GAAP financial measure, that is most directly comparable to each non-GAAP financial measure. Specifically, the non-GAAP financial measures exclude stock-based compensation expense and depreciation and amortization of intangibles. The Company’s management believes that these non-GAAP financial measures are useful to both management and investors in analyzing its ongoing business and operating performance. Management does not intend the presentation of these non-GAAP financial measures to be considered in isolation or as a substitute for results prepared in accordance with GAAP, but as a complement to provide greater transparency. In addition, these non-GAAP financial measures may differ from similarly named measures used by other companies.

About TAZVERIK (tazemetostat)

TAZVERIK is a methyltransferase inhibitor indicated for the treatment of:

Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.

Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.

Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.

These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications is contingent upon verification and description of clinical benefit in confirmatory studies.

The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

View the U.S. Full Prescribing Information here: Epizyme.com.

About EZM0414

EZM0414 is a potent selective, oral, small molecule, investigational drug agent that inhibits the histone methyltransferase, SETD2, which plays a role in oncogenesis. SETD2 methylates histone as well as non-histone proteins, and this activity is involved in several key biological processes including transcriptional regulation, RNA splicing, and DNA damage repair. Based on the preclinical data on SETD2 inhibition by EZM0414 in multiple settings, including high risk t(4;14) multiple myeloma (MM) and in other B-cell malignancies such as diffuse large B-cell lymphoma (DLBCL), the Company is conducting SET-101, a Phase 1/1b study of EZM0414, for the treatment of adult patients with relapsed or refractory MM and DLBCL.

On May 10, 2022 Pfizer Inc. (NYSE: PFE) and Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) reported that the companies have entered into a definitive agreement under which Pfizer will acquire Biohaven, the maker of NURTEC ODT, an innovative dual-acting migraine therapy approved for both acute treatment and episodic prevention of migraine in adults (Press release, Pfizer, MAY 10, 2022, View Source [SID1234614097]).

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Under the terms of the agreement, Pfizer will acquire all outstanding shares of Biohaven not already owned by Pfizer for $148.50 per share in cash. Biohaven common shareholders, including Pfizer, will also receive 0.5 of a share of New Biohaven, a new publicly traded company that will retain Biohaven’s non-CGRP development stage pipeline compounds, per Biohaven common share. The boards of directors of both

Biohaven and Pfizer have unanimously approved the transaction. Pfizer will pay transaction consideration totaling approximately $11.6 billion in cash. Pfizer will also make payments at closing to settle Biohaven’s third party debt and for the redemption of all outstanding shares of Biohaven’s redeemable preferred stock. The $148.50 cash consideration represents a premium of approximately 33% to Biohaven’s volume weighted average selling price of $111.70 over the three months prior to the announcement of the transaction.

The proposed transaction includes the acquisition of Biohaven’s calcitonin gene-related peptide (CGRP) programs including:

Rimegepant:

Approved in the United States (U.S.) under the trade name, NURTEC ODT, for both the acute treatment of migraine and preventive treatment of episodic migraine

Approved in the European Union under the trade name, VYDURA, for both acute treatment of migraine and prophylaxis of episodic migraine

Zavegepant:

On track for a 2Q2022 acceptance (based on March 2022 submission) in the U.S. as an intranasal spray for the acute treatment of migraine and in development as an oral soft gel for chronic migraine prevention

A portfolio of five pre-clinical CGRP assets

"Today’s announcement builds on our legacy of delivering breakthroughs for patients living with complex pain disorders and diseases that disproportionately impact women," said Nick Lagunowich, Global President, Pfizer Internal Medicine. "NURTEC ODT, which is already the #1 prescribed migraine medicine in its class in the United States, coupled with Biohaven’s CGRP pipeline, offers hope for patients suffering from migraine worldwide. We believe Pfizer is uniquely positioned to help the portfolio reach its full potential given our leading scale and capabilities, including comprehensive field force engagement with Primary Care Physicians, specialists and health systems delivering the right information at the right time."

This agreement follows on the November 9, 2021 collaboration for the commercialization of rimegepant and zavegepant outside the United States, in connection with which Pfizer invested $350 million to acquire 2.6% of Biohaven’s common stock at $173 per share.

"We are excited to announce Pfizer’s proposed acquisition of Biohaven, recognizing the market leadership of NURTEC ODT, our breakthrough all in one migraine therapy, and the untapped potential of our CGRP franchise," said Vlad Coric, MD, Chairman and Chief Executive Officer of Biohaven. "Pfizer’s capabilities will accelerate our mission to deliver our migraine medicines to even more patients, while the new R&D company is well positioned to bring value to patients and shareholders by focusing on our innovative pipeline for neurological and other disorders. We believe this transaction represents significant future value creation for patients and our collective shareholders."

Following the closing, New Biohaven will continue to operate under the Biohaven name. New Biohaven will be led by Vlad Coric, MD, as Chairman and CEO, and include other members of the current management team of Biohaven. Biohaven common shareholders will receive, for each Biohaven share, 0.5 of a share of New Biohaven distributed via a pro rata distribution of SEC-registered, publicly listed shares. At distribution, New Biohaven will be capitalized with $275 million of cash. New Biohaven will also have the right to receive tiered royalties from Pfizer on any annual net sales of rimegepant and zavegepant in the United States in excess of $5.25 billion.

Pfizer expects to finance the transaction with existing cash on hand.

Pfizer’s acquisition of Biohaven is subject to the completion of the New Biohaven spin-off transaction and other customary closing conditions, including receipt of regulatory approvals and approval by Biohaven’s shareholders. The companies expect the transaction to close by early 2023.

Due to the proposed transaction, Biohaven will not hold a conference call to discuss its first quarter 2022 financial results and will issue a press release and file a quarterly report on Form 10-Q with the U.S. Securities and Exchange Commission announcing those results on May 10, 2022.

J.P. Morgan acted as Pfizer’s financial advisor for the transaction with Ropes & Gray LLP acting as its legal advisor. Centerview Partners acted as Biohaven’s financial advisor for the transaction with Sullivan & Cromwell LLP acting as its legal advisor.

Investor Call Details

Pfizer and Biohaven will host an analyst and investor call today at 10am EDT to discuss the proposed transaction.

Webcast Details | Pfizer Analyst and Investor Call | May 10

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About Migraine

Around one billion people suffer from migraine across the globe, of which 75 percent are women. The World Health Organization classifies migraine as one of the 10 most disabling medical illnesses. There is a large unmet need for new acute and preventive treatments, as a significant portion of migraine patients are unsatisfied with current standard of care migraine treatments due to a lack of efficacy or safety or tolerability burden.

About Rimegepant

Rimegepant targets a root cause of migraine by reversibly blocking CGRP receptors, thereby inhibiting the biologic cascade that results in a migraine attack. Rimegepant was approved by the U.S. Food and Drug Administration (FDA) under the trade name NURTEC ODT for the acute treatment of migraine in February 2020 and for the preventive treatment of episodic migraine in May 2021. In April 2022, the European Commission (EC) granted marketing authorization for VYDURA (rimegepant) for both the acute treatment of migraine with or without aura, and prophylaxis of episodic migraine in adults who have at least four migraine attacks per month. NURTEC ODT is the #1 prescribed migraine treatment in its class with a cumulative launch to date of U.S. net revenue of approximately $650 million and with more than two million prescriptions. A single dose of 75 mg NURTEC ODT provides fast pain relief, significant pain reduction and return to normal function, and has a lasting effect of up to 48 hours in some patients. NURTEC ODT is taken orally as needed, up to 18 doses/month to stop migraine attacks or taken every other day to help prevent migraine attacks and reduce the number of monthly migraine days. NURTEC ODT does not have addiction potential and is not associated with medication overuse headache or rebound headache.

About Zavegepant

Zavegepant is a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist from Biohaven’s NOJECTION Migraine Platform and the only CGRP receptor antagonist in clinical development with both intranasal and oral formulations. The efficacy and safety profile of intranasal zavegepant for the acute treatment of migraine, as compared to placebo, was shown in a randomized controlled Phase 2/3 dose-ranging trial with a total of over 1000 patients who received zavegepant. In this study, zavegepant showed statistical superiority to placebo on the coprimary endpoints of 2-hour freedom from pain and freedom from a patients’ most bothersome symptom (either nausea, photophobia or phonophobia). This was the second zavegepant pivotal clinical trial to meet these coprimary endpoints. Biohaven plans to file a new drug application with the U.S. Food and Drug Administration for zavegepant in the second quarter of 2022.

NURTEC ODT U.S. IMPORTANT SAFETY INFORMATION

NURTEC ODT (orally disintegrating tablet) is a prescription medicine that is used to treat migraine in adults. It is for the acute treatment of migraine attacks with or without aura and the preventive treatment of episodic migraine. It is not known if NURTEC ODT is safe and effective in children.

Do not take NURTEC ODT if you are allergic to NURTEC ODT (rimegepant) or any of its ingredients.

Before you take NURTEC ODT, tell your healthcare provider (HCP) about all your medical conditions, including if you:

have liver problems,

have kidney problems,

are pregnant or plan to become pregnant,

are breastfeeding or plan to breastfeed.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

NURTEC ODT may cause serious side effects including allergic reactions, including trouble breathing and rash. This can happen days after you take NURTEC ODT. Call your HCP or get emergency help right away if you have swelling of the face, mouth, tongue, or throat or trouble breathing. This occurred in less than 1% of patients treated with NURTEC ODT.

The most common side effects of NURTEC ODT were nausea (2.7%) and stomach pain/indigestion (2.4%). These are not the only possible side effects of NURTEC ODT. Tell your HCP if you have any side effects.

You are encouraged to report side effects of prescription drugs to the FDA. Visit View Source or call 1-800-FDA-1088 or report side effects to Biohaven at 1-833-4Nurtec.