On January 26, 2022 Abbott (NYSE: ABT) reported that financial results for the fourth quarter and full year ended Dec. 31, 2021, and issued its financial outlook for 2022 (Press release, Abbott, JAN 26, 2022, View Source [SID1234607389]).

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Fourth-quarter sales of $11.5 billion increased 7.2 percent on a reported basis and 7.7 percent on an organic basis, which excludes the impact of foreign exchange.
Fourth-quarter GAAP diluted EPS was $1.11 and adjusted diluted EPS, which excludes specified items, was $1.32.
Full-year 2021 GAAP diluted EPS from continuing operations was $3.94 and adjusted diluted EPS from continuing operations was $5.21, reflecting 42.7% growth versus the prior year.1
Global COVID-19 testing-related sales were $2.3 billion in the fourth quarter and $7.7 billion for the full-year. Abbott has distributed more than 1.4 billion COVID-19 tests since the start of the pandemic.
Abbott issues full-year 2022 guidance for diluted EPS from continuing operations on a GAAP basis of at least $3.43 and full-year adjusted diluted EPS from continuing operations of at least $4.70.
Full-year 2022 guidance includes an initial COVID-19 testing-related sales forecast of $2.5 billion, which Abbott expects to occur early in the year and will update on a quarterly basis.
Abbott’s R&D pipeline continues to deliver a steady cadence of new products. Select 2021 highlights include U.S. Centers for Medicare & Medicaid Services expanded reimbursement for MitraClip, U.S. launches of Amplatzer Amulet, NeuroSphere Virtual Clinic, and Portico transcatheter aortic valve replacement (TAVR) system, along with the international launch of Navitor TAVR system.
"2021 was an outstanding year for Abbott," said Robert B. Ford, chairman and chief executive officer, Abbott. "We achieved more than 40 percent EPS growth, exceeding the baseline EPS guidance we set at the beginning of last year and, importantly, continued to advance our new product pipeline across the portfolio."

FOURTH-QUARTER BUSINESS OVERVIEW
Note: Management believes that measuring sales growth rates on an organic basis is an appropriate way for investors to best understand the underlying performance of the business. Organic sales growth excludes the impact of foreign exchange.

Following are sales by business segment and commentary for the fourth quarter 2021:

* Total Q4 2021 Abbott sales from continuing operations include Other Sales of approximately $3 million.

* Total 12M 2021 Abbott sales from continuing operations include Other Sales of approximately $52 million.

n/a = Not Applicable.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Fourth-quarter 2021 worldwide sales of $11.5 billion increased 7.2 percent on a reported basis and 7.7 percent on an organic basis. Full-year 2021 worldwide sales increased 24.5 percent on a reported basis and 22.9 percent on an organic basis.

Worldwide sales, excluding COVID-19 testing-related sales,2 increased 9.6 percent on a reported basis and 10.3 percent on an organic basis in the fourth quarter, and 15.2 percent on a reported basis and 13.7 percent on an organic basis in the full year 2021.

Compared to pre-pandemic sales in 2019, worldwide sales, excluding COVID-19 testing-related sales,3 increased 10.0 percent on a reported basis and 10.8 percent on an organic basis in the fourth quarter.

Worldwide Nutrition sales increased 5.5 percent on a reported basis and 5.9 percent on an organic basis in the fourth quarter.

In Adult Nutrition, strong performance of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading diabetes nutrition brand, led to global sales growth of 8.1 percent on a reported basis and 9.0 percent on an organic basis.

Worldwide Pediatric Nutrition sales increased 3.1 percent on both a reported basis and organic basis. Strong performance of Abbott’s market-leading oral hydration brand, Pedialyte, and continued share growth in infant nutrition led to U.S. Pediatric Nutrition growth of 14.5 percent. In International Pediatric Nutrition, sales were unfavorably impacted primarily by challenging market conditions in China.

Worldwide Diagnostics sales increased 2.9 percent on a reported basis in the fourth quarter and increased 3.3 percent on an organic basis. Global COVID-19 testing-related sales were $2.3 billion in the fourth quarter, including combined sales of $2.1 billion from Abbott’s BinaxNOW, Panbio and ID NOW rapid testing platforms.

Excluding COVID-19 testing-related sales, worldwide Diagnostics sales increased 8.2 percent on a reported basis in the fourth quarter and 8.7 percent on an organic basis.4

In Molecular Diagnostics, fourth-quarter sales growth was negatively impacted by lower COVID-19 testing-related sales compared to the prior year. Excluding COVID-19 testing-related sales, worldwide Molecular Diagnostics sales increased 24.1 percent on a reported basis and 24.5 percent on an organic basis, including 34.6 percent in the U.S. and 20.7 percent internationally.5

In Rapid Diagnostics, fourth-quarter international sales growth was negatively impacted by lower COVID-19 testing-related sales compared to the prior year. Excluding COVID-19 testing-related sales, international Rapid Diagnostics sales increased 9.7 percent on a reported basis and 10.3 percent on an organic basis.6

Established Pharmaceuticals sales increased 4.9 percent on a reported basis in the fourth quarter and increased 5.8 percent on an organic basis.

Key Emerging Markets include India, Brazil, Russia and China along with several additional emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies increased 4.1 percent on a reported basis in the quarter and increased 5.2 percent on an organic basis. Organic sales growth was led by strong growth across several geographies, including India, Russia and China.

Other sales increased 6.8 percent on a reported basis in the quarter and increased 7.5 percent on an organic basis.

Worldwide Medical Devices sales increased 15.1 percent on a reported basis in the fourth quarter and increased 15.9 percent on an organic basis. Strong growth in the quarter was driven by continued recovery from the COVID-19 pandemic and strong growth in Diabetes Care.

Compared to pre-pandemic sales in 2019, Medical Devices sales increased 17.0 percent on a reported basis and 15.8 percent on an organic basis in the fourth quarter, led by double-digit growth in Heart Failure, Structural Heart and Diabetes Care.7

In Diabetes Care, FreeStyle Libre sales were $1.0 billion in the quarter, which represents sales growth of 35.4 percent on a reported basis and 36.0 percent on an organic basis.

Abbott continued to strengthen its Medical Devices portfolio with several pipeline advancements in 2021, including:

U.S. Centers for Medicare & Medicaid Services expanded reimbursement coverage for Abbott’s revolutionary MitraClip device.
U.S. launch of NeuroSphere Virtual Clinic, a first-of-its-kind technology that allows patients to communicate with physicians and receive new treatment settings remotely as needed.
U.S. FDA approval of Amplatzer Amulet Left Atrial Appendage Occluder to treat people with atrial fibrillation who are at risk of ischemic stroke.
U.S. FDA approval of Portico with FlexNav transcatheter aortic valve replacement (TAVR) system to treat people with symptomatic, severe aortic stenosis who are at high risk for open-heart surgery.
CE Mark for Navitor, Abbott’s latest-generation TAVR system.
ABBOTT’S EARNINGS-PER-SHARE GUIDANCE
Abbott projects full-year 2022 diluted earnings per share from continuing operations under GAAP of at least $3.43. Abbott forecasts specified items for the full-year 2022 of $1.27 per share primarily related to intangible amortization, restructuring and cost reduction initiatives, expenses associated with acquisitions and other net expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be at least $4.70 for the full-year 2022.

Abbott projects first-quarter 2022 diluted earnings per share from continuing operations under GAAP of at least $1.20. Abbott forecasts specified items for the first-quarter 2022 of $0.30 per share primarily related to intangible amortization, restructuring and cost reduction initiatives, expenses associated with acquisitions and other net expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be at least $1.50 for the first quarter.

ABBOTT DECLARES 392ND CONSECUTIVE QUARTERLY DIVIDEND
On Dec. 10, 2021, the board of directors of Abbott declared the company’s quarterly dividend of $0.47 per share. Abbott’s cash dividend is payable Feb. 15, 2022 to shareholders of record at the close of business on Jan. 14, 2022.

Abbott has increased its dividend payout for 50 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

On January 26, 2022 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported financial results for the third quarter of fiscal year 2021 and other corporate updates (Press release, Myovant Sciences, JAN 26, 2022, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-announces-financial-results-third-quarter [SID1234607408]).

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"Our third fiscal quarter 2021 financial results reflect the continued strong momentum for the ORGOVYX and MYFEMBREE launches. ORGOVYX volume grew 40% sequentially, reflecting steadily increasing patient and clinician demand for its differentiated clinical profile compared to other androgen deprivation therapy alternatives. By December 2021, MYFEMBREE had captured 45% new-to-brand prescription share among GnRH antagonist therapies FDA-approved for the treatment of uterine fibroids, significant progress only six months following launch. This notable performance for both brands reaffirms our belief that ORGOVYX and MYFEMBREE have the potential to become standard of care therapies in advanced prostate cancer and uterine fibroids, respectively, and represent significant commercial opportunities over time," said David Marek, Chief Executive Officer of Myovant Sciences, Inc.

Mr. Marek added, "We anticipate 2022 will be a significant growth year with several important milestones that will support our mission of redefining care and position Myovant for long-term success. In addition to executing commercially, we look forward to submitting for FDA review the results of the LIBERTY randomized withdrawal study in women with uterine fibroids, completing the two-year SPIRIT long-term extension study of MYFEMBREE in women with endometriosis-associated pain, and potentially launching MYFEMBREE in endometriosis in the U.S. pending FDA approval, while also expanding our pipeline by advancing relugolix lifecycle opportunities and pursuing business development."

Third Fiscal Quarter 2021 and Recent Corporate Updates

ORGOVYX (relugolix 120 mg)

Third fiscal quarter 2021 net product revenues for ORGOVYX in the U.S. were $24.4 million, reflecting 40% sequential volume growth compared to second fiscal quarter 2021, partially offset by a lower net price due to higher gross-to-net discounts. There were no material changes in inventory for ORGOVYX over the course of third fiscal quarter 2021.
Over 1,800 treatment centers prescribed ORGOVYX to approximately 11,000 patients on free and commercial drug, from launch through December 2021, excluding patients utilizing product samples. The cumulative number of estimated patients initiating ORGOVYX therapy has continued to increase steadily in each successive month since launch.
As of January 2022, Myovant achieved 81% commercial coverage and 99% Medicare Part D coverage for ORGOVYX. Myovant continues to engage with key commercial and Part D payers to maintain coverage as well as to potentially expand coverage with payers yet to make a coverage decision.
MYFEMBREE (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg)

Third fiscal quarter 2021 net product revenues for MYFEMBREE in the U.S. were $2.4 million. There were no material changes in inventory for MYFEMBREE over the course of third fiscal quarter 2021.
New-to-brand prescription share among gonadotropin-releasing hormone (GnRH) antagonists approved by the U.S. Food and Drug Administration (FDA) for the treatment of uterine fibroids was 45% in December 2021 compared to 20% in September 2021, reflecting steadily increasing demand for the differentiated clinical profile of MYFEMBREE while growing the class.
Approximately 1,400 patients have been treated with MYFEMBREE from launch through November 2021, including patients on commercial drug and free drug programs, excluding patients utilizing product samples.
From launch through December 2021, over 800 unique providers had prescribed MYFEMBREE, of which 58% had not previously prescribed a GnRH antagonist FDA-approved for the treatment of uterine fibroids.
As of January 2022, Myovant achieved 83% commercial coverage for MYFEMBREE. Myovant continues to engage with key commercial payers to maintain coverage as well as to potentially expand coverage with payers yet to make a coverage decision.
RYEQO (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg)

Since regulatory approvals for RYEQO by the European Commission (EC) in July 2021 and Medicines and Healthcare products Regulatory Agency in August 2021, Gedeon Richter (Richter), Myovant’s commercialization partner in certain other international markets, has launched RYEQO in 12 countries.
Third fiscal quarter 2021 net product revenues for RYEQO were $2.4 million, composed of $2.3 million related to product supply to Richter and $0.1 million royalties on net sales of RYEQO in Richter’s Territory.
Ex-U.S. Rights to Relugolix in Oncology

Myovant is continuing to assess partnership opportunities with multiple interested parties for international commercialization and development rights (excluding Canada and certain Asian countries) to relugolix in oncology. Myovant’s goal is to reach agreement with a partner by the anticipated EC approval of relugolix for prostate cancer, expected in mid-calendar year 2022.
Board of Director Appointment

Effective on November 5, 2021, Dr. Nancy Valente, M.D. was appointed by Myovant’s Board as an independent director following Ms. Kathleen Sebelius’ retirement from Myovant’s Board. Dr. Valente also became a member of the Audit Committee and the Chair of the Nominating and Corporate Governance Committee of Myovant’s Board.
Expected Upcoming Milestones

FDA submission of the Phase 3 LIBERTY randomized withdrawal study results for MYFEMBREE in women with uterine fibroids is expected in the first quarter of calendar year 2022.
Two-year data from the SPIRIT long-term extension study of MYFEMBREE in women with endometriosis-associated pain is expected in the first quarter of calendar year 2022.
FDA decision for the MYFEMBREE sNDA seeking approval for the management of moderate to severe pain associated with endometriosis is expected by its May 6, 2022 target action date. FDA approval of MYFEMBREE for this indication would trigger a $100.0 million regulatory milestone payment from Pfizer. If approved by May 6, 2022, Myovant and Pfizer expect to launch MYFEMBREE in the U.S. for this indication in May 2022. If approved, this indication would utilize the same dosage, formulation, administration, and branding as MYFEMBREE, which was previously approved by the FDA in May 2021 for the management of heavy menstrual bleeding associated with uterine fibroids.
EC decision on the advanced prostate cancer Marketing Authorisation Application is expected in mid-calendar year 2022.
European Medicines Agency regulatory submission for RYEQO for the treatment of women with endometriosis-associated pain is expected in calendar year 2022. Richter will be the sponsor.
Third Fiscal Quarter 2021 Financial Summary

Total revenues for the three months ended December 31, 2021 were $54.4 million compared to $1.4 million for the three months ended December 31, 2020.

Product revenue, net from sales of ORGOVYX and MYFEMBREE in the U.S. for the three months ended December 31, 2021 were $24.4 million and $2.4 million, respectively. For the three months ended December 31, 2021 product revenue, net also includes revenues related to product supply to Richter of $2.3 million, as well as royalties on net sales of RYEQO in Richter’s Territory of $0.1 million. There was no such revenue recorded in the comparable prior year period.
Pfizer collaboration revenue for the three months ended December 31, 2021 was $25.2 million, reflecting the partial recognition of the upfront payment Myovant received from Pfizer upon entering into the Pfizer Collaboration and License Agreement in December 2020 and of the regulatory milestone payment from Pfizer that was triggered upon the FDA approval of MYFEMBREE for the management of heavy menstrual bleeding associated with uterine fibroids in May 2021. Pfizer collaboration revenue in the three months ended December 31, 2020 was $1.4 million, reflecting the partial recognition of the upfront payment received from Pfizer.
Cost of product revenue for the three months ended December 31, 2021 was $4.2 million related to the cost of goods sold and royalty expense payable to Takeda pursuant to the Takeda License Agreement. There were no such amounts recognized in the comparable prior year period.

Collaboration expense to Pfizer for the three months ended December 31, 2021, was $12.1 million, reflecting Pfizer’s 50% share of net profits from sales of ORGOVYX and MYFEMBREE in the U.S., pursuant to the Pfizer Collaboration and License Agreement. There were no such amounts recognized in the comparable prior year period.

Research and development (R&D) expenses for the three months ended December 31, 2021, were $25.7 million compared to $30.5 million for the comparable prior year period. The decrease in R&D expenses primarily reflects a reduction in clinical study costs as a result of the completion and wind down of Myovant’s Phase 3 LIBERTY, HERO, and SPIRIT studies, as well as higher cost sharing with Pfizer for certain R&D expenses.

Selling, general and administrative (SG&A) expenses for the three months ended December 31, 2021, were $72.1 million compared to $49.2 million for the comparable prior year period. The increase was primarily due to higher expenses to support the ORGOVYX and MYFEMBREE U.S. launches, including higher personnel-related costs primarily due to the hiring of Myovant’s commercial operations, marketing, and market access teams, as well as the oncology and women’s health sales forces.

Interest expense was $3.5 million for the three months ended December 31, 2021, compared to $2.6 million for the comparable prior year period. The increase in interest expense was primarily driven by the higher balance under Myovant’s loan agreement with Sumitomo Dainippon Pharma (Sumitomo Dainippon Pharma Loan Agreement) and $0.6 million of accretion of the financing component of the cost share advance from Pfizer.

Foreign exchange gain for the three months ended December 31, 2020 was $5.9 million, primarily the result of the impact of fluctuations in the foreign currency exchange rate between the Swiss franc and the U.S. dollar on Myovant’s outstanding balance under the Sumitomo Dainippon Pharma Loan Agreement. As a result of a change in the functional currency of Myovant’s wholly-owned subsidiary in Switzerland, Myovant Sciences GmbH, from the Swiss franc to the U.S. dollar in December 2020, Myovant is no longer exposed to significant foreign currency gains or losses.

Net loss for the three months ended December 31, 2021 was $63.4 million compared to $73.8 million for the comparable prior year period. On a per common share basis, net loss was $0.68 and $0.82 for the three months ended December 31, 2021 and 2020, respectively.

Capital resources: Cash, cash equivalents, marketable securities, and amounts available under the Sumitomo Dainippon Pharma Loan Agreement totaled $569.1 million as of December 31, 2021, and consisted of $527.8 million of cash, cash equivalents, and marketable securities and $41.3 million of available borrowing capacity under the Sumitomo Dainippon Pharma Loan Agreement.

Conference Call
As previously announced, Myovant will hold a webcast and conference call at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) today, January 26, 2022, to discuss financial results for its third fiscal quarter ended December 31, 2021 and corporate updates. Investors and the general public may access a live webcast of the call by visiting the investor relations page of Myovant’s website at investors.myovant.com. Institutional investors and analysts may also participate in the conference call by dialing 1-800-532-3746 in the U.S. or +1-470-495-9166 from outside the U.S. The webcast will be archived on Myovant’s investor relations website following the call.

About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces testicular testosterone, a hormone known to stimulate the growth of prostate cancer, and ovarian estradiol, a hormone known to stimulate the growth of uterine fibroids and endometriosis. ORGOVYX (relugolix 120 mg) was approved in the U.S. by the FDA in December 2020 as the first and only oral GnRH receptor antagonist for the treatment of adult patients with advanced prostate cancer, and relugolix (120 mg) is also under regulatory review in Europe for men with advanced prostate cancer. MYFEMBREE (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) was approved in the U.S. by the FDA in May 2021 as the first and only once-daily oral treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months, and by the European Commission and the Medicines and Healthcare products Regulatory Agency in July 2021 and August 2021, respectively, as RYEQO for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age, with no limitation for duration of use. In September 2021, the FDA accepted Myovant’s supplemental New Drug Application for MYFEMBREE for the management of moderate to severe pain associated with endometriosis, setting a target action date of May 6, 2022. MYFEMBREE is also being assessed for contraceptive efficacy in women with endometriosis or uterine fibroids who are 18 to 50 years of age and at risk for pregnancy.

On January 26, 2022, Epizyme, Inc. (the "Company") reported that entered into an underwriting agreement (the "Underwriting Agreement") with Jefferies LLC, as representative of the several underwriters listed therein (collectively, the "Underwriters"), relating to an underwritten public offering (the "Offering") of 56,666,667 shares (the "Shares") of the Company’s common stock, par value $0.0001 per share (the "Common Stock") at a public offering price of $1.50 per share. All of the Shares are being sold by the Company (Filing, 8-K, Epizyme, JAN 26, 2022, View Source [SID1234607443]). The Underwriters have agreed to purchase the Shares from the Company pursuant to the Underwriting Agreement at a price of $1.41 per share. Under the terms of the Underwriting Agreement, the Company has also granted the Underwriters an option, exercisable for 30 days, to purchase up to an additional 8,500,000 shares of Common Stock (the "Additional Shares"), at the same price per share as the Shares.

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The Company estimates that the net proceeds from the Offering will be approximately $79.5 million, or approximately $91.4 million if the Underwriters exercise in full their option to purchase Additional Shares, in each case, after deducting underwriting discounts and commissions and estimated offering expenses. Based on the Company’s research and development plans and its timing expectations related to the progress of its programs, the Company expects that the net proceeds from the Offering, together with the Company’s existing cash, cash equivalents and marketable securities as of December 31, 2021, and product revenue the Company expects to generate from product sales, will enable the Company to fund its operating expenses and capital expenditure requirements into the third quarter of 2023.

The Shares, and any Additional Shares, will be issued pursuant to a prospectus supplement dated January 26, 2022 and an accompanying base prospectus dated May 13, 2021 that form a part of the registration statement on Form S-3 that the Company filed with the U.S. Securities and Exchange Commission ("SEC") (File No. 333-255806), which was declared effective by the SEC on May 13, 2021. The closing of the Offering is expected to take place on or about January 31, 2022, subject to the satisfaction of customary closing conditions.

The Underwriting Agreement contains customary representations, warranties, covenants and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties. A copy of the Underwriting Agreement is attached as Exhibit 1.1 hereto and is incorporated herein by reference. The foregoing description of the material terms of the Underwriting Agreement does not purport to be complete and is qualified in its entirety by reference to such exhibit.

On January 26, 2022 Nordic Pharma reported that on the 24th of January, the European Commission (EC) approved the new indication for Teysuno (tegafur/gimeracil/oteracil) for the treatment of patients with metastatic colorectal cancer who cannot continue fluoropyrimidine treatment due to specific toxicities: hand-foot syndrome and cardiotoxicity (Press release, Nordic Pharma, JAN 26, 2022, View Source [SID1234607539]).

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Nordic Pharma received a positive scientific opinion recommending approval of the use of Teysuno in metastatic colorectal cancer from EMA’s Committee for Medicinal Products for Human Use (CHMP) in December 2021.

Based on this approval, Teysuno will be indicated in adults:

for the treatment of advanced gastric cancer when given in combination with cisplatin (current indication).
as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity that developed in the adjuvant or metastatic setting

New fluoropyrimidine for patients with metastatic colorectal cancer

nordic_pharma_thumbnail_green_colon

In metastatic colorectal cancer the typical first-line chemotherapy consists of a fluoropyrimidine used in various combinations.

Teysuno is an oral fluoropyrimidine with similar efficacy, but improved specific safety profile compared with other fluoropyrimidines.

Jean-Michel Quinot, CEO of Nordic Pharma stated: "This is important news for patients with metastatic colorectal cancer. Teysuno offers those patients suffering from toxicities that can cause discontinuation of therapy an alternative fluoropyrimidine therapy which allows them to continue systemic treatment that is known to significantly prolong survival. By being able to meet this medical need, we hope to contribute to improving the lives of these patients. We want to particularly thank medical oncologists and patients in different European countries who contributed to collecting crucial clinical data for this new indication."

Iris van Lakerveld, Global Oncology Lead added: "Fluoropyrimidines are, and will continue to be, the cornerstone of chemotherapy treatment in metastatic colorectal cancer. A significant group of patients can now be offered an alternative, in the event that chemotherapy needs to be delayed, the dose reduced or fully stopped because of hand-foot syndrome or cardiotoxicity. Side effects with chemotherapy are inevitable. With Teysuno, physicians and patients will have an additional therapy when needed, allowing optimal benefit of fluoropyrimidine treatment.

Nordic Pharma licences Teysuno from Taiho Pharmaceutical Co., Ltd. in Japan. In Japan, the product is known as TS-1 and is approved for various solid tumours, including gastric and colorectal cancer. Since 2011 Teysuno has been on the European market in 17 countries. In total, the product is marketed in over 30 countries worldwide. The approval of the European Commission is an important step in providing patients with metastatic colorectal cancer access to Teysuno. Subsequently country-specific reimbursement applications will be done at the level of each Member State to ensure this access.

On January 26, 2022 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune and infectious diseases reported approval from the United States Food and Drug Administration (FDA) of KIMMTRAK (tebentafusp-tebn) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM) (Press release, Immunocore, JAN 26, 2022, View Source [SID1234607391]).

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KIMMTRAK’s approval establishes many firsts as the first TCR therapeutic to receive regulatory approval from the FDA, the first bispecific T cell engager to receive regulatory approval from the FDA to treat a solid tumor, and the first and only therapy for the treatment of unresectable or metastatic uveal melanoma to be approved by the FDA.

Bahija Jallal, Chief Executive Officer of Immunocore, said: "Today’s approval of KIMMTRAK is a historic milestone and the culmination of years of dedication by the Immunocore team, patients, and our healthcare partners. Every year in the United States, hundreds of people are diagnosed with metastatic uveal melanoma who, until now, had no approved treatment options. KIMMTRAK is the first therapy to demonstrate a survival benefit to patients with this disease and we are focused on making KIMMTRAK available as quickly as possible.

Dr. Jallal continues, "We’re also proud to have developed the world’s first approved TCR therapeutic, which we believe validates the strength of our platform and opens doors for us to explore further breakthrough discoveries in TCR therapeutics for the treatment of other cancers and diseases with high unmet need."

"Uveal melanoma is a devastating disease that has historically resulted in death within a year of metastasis for our patients," said John Kirkwood, MD, director of the Melanoma Center at the UPMC Hillman Cancer Center. "The approval of KIMMTRAK (tebentafusp-tebn) represents a major paradigm shift in the treatment of metastatic uveal melanoma, and for the first time offers hope to those with this aggressive form of cancer."

The approval of KIMMTRAK is based on the results of Immunocore’s Phase 3 IMCgp100-202 clinical trial, which were published in the September 23, 2021 issue of the New England Journal of Medicine. The randomized pivotal trial evaluated overall survival (OS) of KIMMTRAK compared to investigator’s choice (either pembrolizumab, ipilimumab, or dacarbazine) in patients with previously untreated mUM. 378 patients were randomized in a 2:1 ratio to either KIMMTRAK or investigator’s choice. Data from the trial, the largest Phase 3 trial undertaken in mUM, showed that KIMMTRAK demonstrated unprecedented median OS benefit as a first-line treatment. The OS Hazard Ratio (HR) in the intent-to-treat population favored KIMMTRAK, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine). In the clinical trials, across both arms, patients stopped treatment for disease progression, unless the patient was otherwise deriving benefit, or for unacceptable toxicity.

"When my husband, Gregg, was diagnosed with metastatic uveal melanoma, it was devastating to learn that there were no treatment options shown to extend life." said Sara Selig, MD, MPH, Co-Founder and Director of the Melanoma Research Foundation’s (MRF) CURE OM initiative. "Now, for the first time in the history of this disease, we will soon see extended survival in the next generation of metastatic uveal melanoma patients."

In the randomized Phase 3 trial of KIMMTRAK (tebentafusp-tebn), treatment-related adverse reactions were manageable and consistent with the proposed mechanism. Among the patients treated with KIMMTRAK, the most common Grade 3 or higher adverse reactions were rash (18%), pyrexia (4%), and pruritus (5%). In the 245 patients treated with KIMMTRAK, Grade 3 cytokine release syndrome (CRS) occurred in <1% of patients and were generally well-managed. There were no Grade 4 or fatal CRS events observed in the Phase 3 trial. A boxed warning is included for CRS as it has the potential to become serious or life-threatening if not managed appropriately.

"Until now, effective treatment options for metastatic uveal melanoma patients were virtually non-existent. The approval of KIMMTRAK represents not only a new therapy but a new hope for the individuals and the families of those diagnosed with the deadliest form of eye cancer," said Kyleigh LiPira, MBA, CEO of the MRF.

The company is ready to commercialize KIMMTRAK and expects to make the product commercially available in the United States within weeks.

KIMMTRAK was granted Breakthrough Therapy Designation for unresectable or metastatic uveal melanoma by the FDA in February 2021. The Biologics License Application (BLA) approval followed review under the Real-Time Oncology Review (RTOR) program, an initiative of the FDA’s Oncology Center of Excellence designed for efficient delivery of safe and effective cancer treatments to patients. The approval was granted four weeks ahead of the assigned PDUFA date of February 23, 2022. Immunocore provided an Assessment AID to facilitate FDA review. KIMMTRAK is being reviewed under the FDA’s Project Orbis initiative, which enabled concurrent review by the health authorities in partner countries that have requested participation.

The European Medicines Agency (EMA), the United Kingdom’s Medicines and Healthcare Regulatory Agency (MHRA), Health Canada, and the Australian Government Department of Health Therapeutic Goods Administration (TGA) have accepted the submission of the Company’s Marketing Authorisation Application. Additionally, Immunocore launched a global early access program to make KIMMTRAK readily available to mUM patients. There are currently over 200 patients in 13 countries in the early access program.

Immunocore is committed to helping patients who need KIMMTRAK obtain access via its KIMMTRAKConnect program. The program provides services with dedicated nurse case managers who provide personalized support, including educational resources, financial assistance, and site of care coordination. To learn more, visit KIMMTRAKConnect.com, which will launch later this week, or call 844-775-CARE (2273).