On August 12, 2020 Omeros Corporation (Nasdaq: OMER) ("Omeros") reported that it has priced concurrent underwritten public offerings of 6,900,000 of shares of its common stock (the "Shares") at a public offering price of $14.50 per Share for proceeds of approximately $100,050,000, prior to the deduction of underwriting discounts and commissions and estimated offering expenses payable by Omeros (the "Equity Offering"), and $210,000,000 aggregate principal amount of 5.25% convertible senior notes due 2026 (the "2026 Convertible Notes" and such offering, the "Notes Offering") (Press release, Omeros, AUG 12, 2020, View Source [SID1234563525]). In addition, Omeros has granted to the underwriters of the Equity Offering a 30-day option to purchase up to an additional 1,035,000 Shares and to the underwriters of the Notes Offering a 30-day option, solely to cover over-allotments, to purchase up to an additional $31,500,000 aggregate principal amount of 2026 Convertible Notes. The Equity Offering and the Notes Offering are each expected to close on August 14, 2020, subject to customary closing conditions. Neither offering is contingent on the completion of the other offering.

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BofA Securities and JP Morgan are acting as the book-running managers for the Equity Offering. Cantor Fitzgerald is also acting as a book-running manager, and WBB Securities is acting as co-manager, for the Equity Offering. BofA Securities, JP Morgan and RBC Capital Markets are acting as the book-running managers for the Notes Offering.

The 2026 Convertible Notes will be senior unsecured obligations of Omeros and will bear interest at a rate of 5.25% per year, payable semi-annually in arrears. The 2026 Convertible Notes will mature on February 15, 2026, unless earlier converted, repurchased or redeemed in accordance with their terms, and will be convertible, subject to the satisfaction of certain conditions, into cash, shares of Omeros’ common stock or a combination thereof as elected by Omeros in its sole discretion.

The initial conversion rate for the 2026 Convertible Notes is 54.0906 shares of Omeros’ common stock per $1,000 principal amount of 2026 Convertible Notes (which is equivalent to an initial conversion price of approximately $18.49 per share, which represents a premium of approximately 27.5% over the public offering price of Omeros’ common stock in the Equity Offering of $14.50 per share). Omeros will have the right to redeem the 2026 Convertible Notes on or after August 15, 2023, subject to certain conditions and limitations.

The Equity Offering is expected to result in approximately $93.7 million in net proceeds to Omeros, and the Notes Offering is expected to result in approximately $203.7 million in net proceeds to Omeros, in each case, after deducting underwriting discounts and commissions and estimated offering expenses payable by Omeros, and in each case, assuming no exercise of the underwriters’ option to purchase additional Shares or 2026 Convertible Notes.

Omeros intends to use approximately $21.7 million of the net proceeds of the Notes Offering to fund the cost of entering into capped call transactions with the option counterparties, as described below. In addition, Omeros intends to use approximately $127.4 million of the net proceeds of the Notes Offering to repurchase approximately $115 million aggregate principal amount of its existing 6.25% Convertible Senior Notes due 2023 (the "2023 Convertible Notes") in privately negotiated transactions as described below, and expects to receive approximately $8.4 million from unwinding a proportionate amount of the capped call transaction that it entered into with a financial institution (the "existing option counterparty") in connection with the issuance of the 2023 Convertible Notes (the "existing capped call transaction").

Omeros intends to use the net proceeds from the Equity Offering and the remainder of the net proceeds from the Notes Offering for general corporate purposes, including funding clinical trials, pre-clinical studies, manufacturing, build-out of commercial infrastructure and other costs associated with advancing its development programs and product candidates toward regulatory submissions and potential commercialization.

In connection with the pricing of the 2026 Convertible Notes, Omeros entered into privately negotiated capped call transactions with certain financial institutions ("option counterparties"). The capped call transactions are intended to reduce the potential dilution with respect to Omeros’ common stock or, at its election (subject to certain conditions), offset potential cash payments in excess of the principal amount of the converted 2026 Convertible Notes, upon conversion of the 2026 Convertible Notes, with such reduction or offset subject to a cap of $26.10, representing a premium of 80% over the public offering price of Omeros’ common stock in the Equity Offering. If the underwriters exercise their option to purchase additional 2026 Convertible Notes, Omeros expects to enter into additional capped call transactions with the option counterparties.

Omeros has been informed that in connection with establishing their initial hedges of the capped call transactions, the option counterparties and/or their affiliates expect to purchase shares of Omeros’ common stock and/or enter into various derivative transactions with respect to Omeros’ common stock concurrently with or shortly after the pricing of the 2026 Convertible Notes. This activity could increase (or reduce the size of any decrease in) the market price of Omeros’ common stock or the 2026 Convertible Notes at that time.

In addition, the option counterparties and/or their affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Omeros’ common stock and/or purchasing or selling Omeros’ common stock or other securities of Omeros’ in secondary market transactions prior to the maturity of the 2026 Convertible Notes (and are likely to do so on each exercise date of the capped call transactions, which are expected to occur during the 50-trading day period beginning on the 51st scheduled trading day prior to the maturity date of the notes, or following any termination of any portion of the capped call transactions in connection with any repurchase, redemption or conversion of the 2026 Convertible Notes if Omeros makes the relevant election under the capped call transactions). This activity could also cause or avoid an increase or a decrease in the market price of Omeros’ common stock or the 2026 Convertible Notes, which could affect a noteholder’s ability to convert the 2026 Convertible Notes and, to the extent the activity occurs during any observation period related to a conversion of the 2026 Convertible Notes, could affect the amount and value of the consideration that a noteholder will receive upon conversion of the 2026 Convertible Notes.

Concurrently with the Notes Offering, Omeros intends to use approximately $127.4 million of the proceeds from the offering to repurchase approximately $115 million aggregate principal amount of its outstanding 2023 Convertible Notes in privately negotiated transactions. Omeros expects that holders of the 2023 Convertible Notes that sell their 2023 Convertible Notes to Omeros in any note repurchase transaction may enter into or unwind various derivatives with respect to Omeros’ common stock and/or purchase or sell shares of Omeros’ common stock in the market to hedge their exposure in connection with these transactions. This activity could increase (or reduce the size of any decrease in) the market price of Omeros’ common stock or the 2026 Convertible Notes at that time and could result in a higher effective conversion price for the 2026 Convertible Notes.

In connection with the repurchase of the 2023 Convertible Notes, Omeros intends to terminate a portion of the existing capped call transaction in a notional amount corresponding to the amount of such 2023 Convertible Notes repurchased. In connection with the partial termination of the existing capped call transaction and the related unwinding of the existing hedge position of the existing option counterparty with respect to such transaction, the existing option counterparty and/or its respective affiliates are expected to sell shares of Omeros’ common stock in secondary market transactions, and/or enter into or unwind various derivative transactions with respect to Omeros’ common stock. This activity could decrease (or reduce the size of any increase in) the market price of Omeros’ common stock or the 2026 Convertible Notes at that time.

The Equity Offering and the Notes Offering are being made pursuant to Omeros’ shelf registration statement on Form S-3 (File No. 333-235349) including the base prospectus contained therein, and a prospectus supplement related to the Equity Offering (together with such base prospectus, the "Equity Prospectus") and a prospectus supplement related to the Notes Offering (together with such base prospectus, the "Notes Prospectus"), all of which Omeros filed or will file with the Securities and Exchange Commission ("SEC"). Before investing in the Shares or the 2026 Convertible Notes, investors should read the Equity Prospectus and the Notes Prospectus, respectively, in each case, including the documents incorporated by reference therein, and any free writing prospectus related to the Equity Offering and the Notes Offering, as the case may be. These documents may be freely obtained by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, copies may be obtained, when available, from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or via email: [email protected] and J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by e-mail at [email protected].

On August 12, 2020 Verrica Pharmaceuticals Inc. ("Verrica") (NASDAQ: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, reported that the Company has entered into an exclusive worldwide license agreement with Lytix Biopharma AS ("Lytix") to develop and commercialize LTX-315 for dermatologic oncology indications (Press release, Verrica Pharmaceuticals, AUG 12, 2020, View Source [SID1234563524]). Verrica intends to focus initially on basal cell and squamous cell carcinomas as the lead indications for development. LTX-315 is a first-in-class oncolytic peptide that is injected directly into a tumor to induce immunogenic cell death. The compound has demonstrated positive tumor-specific immune cell responses in multi-indication Phase I/II oncology trials.

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"This is an important milestone in the broadening of Verrica’s strategy to bring breakthrough treatments for skin diseases to patients and physicians, as dermatologic cancers are highly prevalent and many patients suffer from them," said Dr. Gary Goldenberg, Verrica’s Chief Medical Officer. "Innovation in dermatology is one of the primary drivers that prompted me to recently join Verrica, and LTX-315’s unique mechanism of action is clearly an innovative approach to potentially provide significant improvement over invasive surgery. LTX-315 has the potential to revolutionize one of the most common disease states in dermatology – non-melanoma skin cancers. We look forward to leveraging Verrica’s depth of clinical development experience to develop this innovative asset for the potential benefit of patients. We intend to submit an IND in the United States for LTX-315 during the first half of 2021 and commence clinical development thereafter."

"Skin cancer is the most common cancer in the U.S., with 5 million diagnoses of basal and squamous cell carcinomas each year,"1 said Darrell Rigel, MD, Clinical Professor of Dermatology at NYU. "Patients are typically treated with surgery, which can result in damage to healthy tissue, pain, and permanent scarring. LTX-315 is a clinical-stage, non-surgical immunotherapy product candidate that directly targets cancerous skin cells, with the potential to transform the treatment of skin cancer by offering a therapeutic alternative to surgery."

"We are pleased to enter into this collaboration with Verrica, which has significant expertise within the field of dermatology," said Øystein Rekdal, Lytix`s CEO. "Our lead drug candidate, LTX-315, has shown very promising efficacy and safety signals in cancer patients during Phase I/II studies and we are excited that this partnership with Verrica will expand the applications for LTX-315."

Under the terms of the agreement, Lytix will be entitled to receive an upfront payment, contingent regulatory milestones based on achievement of specified development goals, and sales milestones, with aggregate payments of up to $113.5 million, in addition to tiered royalties based on worldwide annual sales. The agreed upon royalty rates start in the low double digits and increase to the mid-teens based on net sales achieved.

Verrica is solely responsible for the development, regulatory filings, and commercialization of LTX-315 in dermatology, while Lytix is responsible for manufacturing the active pharmaceutical ingredient. The license includes worldwide rights for Verrica to develop and commercialize LTX-315 for all malignant and pre-malignant dermatological indications, except for metastatic melanoma and metastatic Merkel cell carcinoma.

The Company reaffirms its belief that its existing cash, cash equivalents, and marketable securities will be sufficient to support planned operations, inclusive of this agreement with Lytix and LTX-315 development activities, at least through the fourth quarter of 2021.

On August 12, 2020 Saniona (OMX: SANION), a clinical stage biopharmaceutical company focused on rare diseases, reported a conference call and webcast presentation regarding its recent directed share issue generating gross proceeds of USD 65 million (approximately SEK 567 million) (Press release, Saniona, AUG 12, 2020, View Source [SID1234563523]).

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The event will take place on Friday August 14th at 2 p.m. CET and will feature a presentation by Saniona’s management team to discuss the strategy and rationale for the financing, as well as an update on Saniona’s advancement of its late-stage clinical trials with Tesomet in two rare eating disorders, hypothalamic obesity (HO) and Prader Willi Syndrome (PWS), as well as progress building its U.S.-based organization in support of these programs.

View Source

Event number: 137 140 9570

Please add your questions in the Q&A field during the presentation.

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AUDIO DETAILS

US: +1 408 758 98 56 Global call-in numbers

Event number: 137 140 9570

For those who are unable to listen at this time, a replay of the call will be available after the event through the investor section of Saniona’s web site at View Source

On August 12, 2020 Bristol Myers Squibb (NYSE: BMY) and the Bristol Myers Squibb Foundation reported a combined investment of $300 million as part of a series of commitments (Press release, Bristol-Myers Squibb, AUG 12, 2020, View Source [SID1234563519]). For Bristol Myers Squibb and the Bristol Myers Squibb Foundation, the commitments are designed to address health disparities, increase clinical trial diversity and for Bristol Myers Squibb, to increase the company’s spend with diverse suppliers and continue to increase Black/African American and Hispanic/Latino representation at all levels of the company. These commitments build on each entity’s experience addressing health disparities and, for Bristol Myers Squibb, its investments in increasing the diversity of its workforce.

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The combined $300 million investment to health equity focuses on raising disease awareness and education, increasing health care access, and improving health outcomes for medically underserved populations. The BMS Foundation’s commitment to clinical trial diversity focuses on building clinical trial infrastructure in diverse communities and high disease burden areas in the U.S. and increasing the diversity of investigators through a fellowship program over five years.

"Our company has a long history of addressing health disparities as part of our overall mission to serve patients with serious disease," said Giovanni Caforio, M.D., chairman and chief executive officer, Bristol Myers Squibb. "Now more than ever, we recognize the urgent need to do more to address serious gaps in care among the underserved in communities around the world. This commitment reflects our belief that investments toward achieving health equity, and increasing diversity and inclusion are opportunities to advance our vision of transforming patients’ lives through science."

This investment follows Bristol Myers Squibb’s previous announcement to expand its existing patient support program to help eligible unemployed patients in the U.S. who have lost their health insurance due to the COVID-19 pandemic. In recent months, though, COVID-19 has exposed the severity of social and health disparities in the U.S. that increase the risk for infection and poorer health outcomes for Black/African American and Hispanic/Latino communities.

Bristol Myers Squibb and the Bristol Myers Squibb Foundation recognize the need to take concrete steps to better serve and collaborate with an increasingly diverse U.S. population and underserved communities around the world.

The commitments include:

Increasing clinical trial diversity: Bristol Myers Squibb will extend the reach of clinical trials into underserved patient communities in urban and rural U.S. geographies. The Bristol Myers Squibb Foundation will train and develop 250 new racially and ethnically diverse clinical investigators who will have mentorship and training opportunities, and ultimately to enroll underserved patients into clinical trials.
"Clinical trial diversity needs acceleration. We see tremendous opportunity for longer-term, sustainable impact by supporting ethnically diverse physician scientists to engage in clinical research while also establishing clinical research sites in diverse communities," said Samit Hirawat, M.D., chief medical officer, Bristol Myers Squibb. "Over the next five years, we will extend the reach of our trials into underserved patient communities and the Bristol Myers Squibb Foundation will train and develop 250 new racially and ethnically diverse clinical investigators that can enroll a diverse patient population in trials conducted across the industry."

Strengthening health equity work across the business: Bristol Myers Squibb will accelerate its efforts to reach at-risk patients with disease awareness and education programs and information about its patient support programs, including programs for people who cannot afford their medicines. Bristol Myers Squibb will also continue to advocate for policies that promote health equity.
Increasing the company’s spend with diverse suppliers: Bristol Myers Squibb will spend $1 billion globally by 2025 with Black/African American and other diverse-owned businesses to help create jobs and generate positive economic impact in diverse communities.
Increasing the diversity of the company’s workforce: Bristol Myers Squibb will expand the diversity of its workforce and leadership to ensure it reflects the evolving demographics of the patients the company serves. The company achieved gender parity across its workforce in 2015. By 2022, Bristol Myers Squibb aims to achieve gender parity at the executive level globally; double executive representation of Black/African American employees in the U.S.; and double executive representation of Hispanic/Latino employees in the U.S.
"As a patient focused company, it is vital that our workforce reflect the people, cultures and communities we serve," added Ann Powell, chief human resources officer, Bristol Myers Squibb. "We recognize that meeting the needs of patients means we must continue to grow a powerfully diverse, and broadly inclusive, workforce."

Expanding our employee giving program: Bristol Myers Squibb Foundation will provide a 2-to-1 match for U.S. employee donations to organizations that fight health disparities and discrimination.
The commitments by the Bristol Myers Squibb Foundation build on the more than 100 active grantee projects funded by the Foundation globally to improve access to care and support, and health outcomes that have reached nearly 1.5 million people worldwide. For more information on these commitments and the work Bristol Myers Squibb is doing to transform patients’ lives through science, visit BMS.com.

On August 12, 2020 AbbVie (NYSE: ABBV) reported the publication of results from the Phase 3 VIALE-A clinical study in patients with AML in the New England Journal of Medicine (NEJM) (Press release, AbbVie, AUG 12, 2020, View Source [SID1234563518]). The study, which evaluated newly-diagnosed AML patients who had not yet been treated and were unable to tolerate traditional intensive chemotherapy, found that venetoclax in combination with azacitidine extended overall survival (OS) compared to azacitidine plus placebo. The manuscript titled, "Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia," was published in the August 13, 2020 issue of NEJM.3

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"The ability of venetoclax plus azacitidine to improve outcomes of newly-diagnosed AML patients unable to tolerate intensive chemotherapy represents a potentially practice-changing advance in AML treatment," said Courtney D. DiNardo, M.D., MSCE, Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center and the lead study investigator.

In the VIALE-A study, OS was the sole primary study endpoint in the U.S. OS and composite complete remission rate (CR+CRi) were co-primary endpoints in China, Japan, the European Union (EU) and EU reference countries. CR+CRi is a composite score reflecting the complete remission (CR) and CR with incomplete hematologic recovery (CRi), which is an incomplete CR with blood counts not fully recovered.4,5 Treatment with venetoclax plus azacitidine reduced the risk of death by 34% compared to azacitidine in combination with placebo (Hazard Ratio [HR]=0.66 [95% CI: 0.52-0.85], p<0.001).3

Patients in the venetoclax combination arm had a median OS of 14.7 months (95% CI: 11.9-18.7) versus 9.6 months for patients in the placebo arm (95% CI: 7.4-12.7). Additionally, 66.4% (95% CI: 60.6-71.9) of patients treated with venetoclax plus azacitidine achieved CR+CRi versus 28.3% (95% CI: 21.1-36.3) of patients treated with azacitidine plus placebo (p<0.001). Other secondary endpoints that were published in NEJM include CR and CR with partial hematologic recovery (CR+CRh).3

The observed safety profile in the VIALE-A trial is generally consistent with the known safety profiles of venetoclax combined with azacitidine. The most common adverse events (AEs [occurring in ≥40% of patients]) in patients receiving venetoclax plus azacitidine were mostly hematologic and gastrointestinal in nature and consisted of thrombocytopenia (46%), nausea (44%), constipation (43%), neutropenia (42%), febrile neutropenia (42%) and diarrhea (41%). The most frequent serious adverse reactions (ARs [occurring in >10% of patients]) in patients receiving venetoclax plus azacitidine were febrile neutropenia (30%) and pneumonia (17%). Tumor lysis syndrome (TLS) was reported during ramp-up in three patients in the venetoclax arm and none in the placebo arm. All were transient biochemical changes that resolved with uricosuric agents – medications that increase excretion of uric acid in the urine and decrease the concentration of uric acid in blood plasma – and calcium supplements without treatment interruption.

The VIALE-A trial results were presented as late-breaking data during the virtual 25th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress in June 2020 (abstract #LB2601).6 AbbVie, in collaboration with Genentech, submitted the results of the VIALE-A (M15-656) trial, along with data from the VIALE-C (M16-043) trial and updated data from the Phase 1/2 studies M14-358 and M14-387, to the U.S. Food and Drug Administration (FDA) to convert the accelerated approval for venetoclax in combination with azacitidine, decitabine, or low-dose cytarabine (LDAC) for the treatment of newly-diagnosed AML in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy, to a full approval. AbbVie also submitted these data to additional health authorities around the world.

AML is the most common acute leukemia in the world.7 Not all patients can tolerate standard intensive chemotherapy,8 making it among the most difficult blood cancers to treat.9 Despite advances in available therapies and care, the five-year survival rate for patients diagnosed with AML remains approximately 28%.10

Venetoclax, known by the brand name VENCLEXTA in the U.S., is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

About the VIALE-A (M15-656) Phase 3 Trial
A total of 433 treatment-naïve, intensive chemotherapy ineligible AML patients were randomized in the double-blind, placebo-controlled Phase 3 VIALE-A trial. The trial was designed to evaluate the efficacy and safety of venetoclax in combination with azacitidine (n=286) compared with azacitidine in combination with placebo (n=145).3

About VENCLEXTA (venetoclax)
VENCLEXTA (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLEXTA targets the BCL-2 protein and works to help restore the process of apoptosis.

VENCLEXTA/VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood and other cancers. VENCLEXTA/VENCLYXTO is approved in more than 50 countries, including the U.S.

Uses and Important VENCLEXTA (venetoclax) U.S. Safety Information11

Uses
VENCLEXTA is a prescription medicine used:

to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who:
are 75 years of age or older, or
have other medical conditions that prevent the use of standard chemotherapy.
VENCLEXTA was approved based on response rates. Continued approval for this use may depend on the results of an ongoing study to find out how VENCLEXTA works over a longer period of time.

It is not known if VENCLEXTA is safe and effective in children.

Important Safety Information

What is the most important information I should know about VENCLEXTA?

VENCLEXTA can cause serious side effects, including:

Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your healthcare provider will do tests to check your risk of getting TLS before you start taking VENCLEXTA. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Your healthcare provider will do blood tests to check for TLS when you first start treatment and during treatment with VENCLEXTA. It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.

Drink plenty of water during treatment with VENCLEXTA to help reduce your risk of getting TLS. Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased.

Your healthcare provider may delay, decrease your dose, or stop treatment with VENCLEXTA if you have side effects.

Who should not take VENCLEXTA?

Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased because of the risk of increased TLS.

Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. VENCLEXTA and other medicines may affect each other causing serious side effects.
Do not start new medicines during treatment with VENCLEXTA without first talking with your healthcare provider.
Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions, including if you:

have kidney or liver problems.
have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium.
have a history of high uric acid levels in your blood or gout.
are scheduled to receive a vaccine. You should not receive a "live vaccine" before, during, or after treatment with VENCLEXTA, until your healthcare provider tells you it is okay. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. These vaccines may not be safe or may not work as well during treatment with VENCLEXTA.
are pregnant or plan to become pregnant. VENCLEXTA may harm your unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with VENCLEXTA, and you should use effective birth control during treatment and for at least 30 days after the last dose of VENCLEXTA. If you become pregnant or think you are pregnant, tell your healthcare provider right away.
are breastfeeding or plan to breastfeed. It is not known if VENCLEXTA passes into your breast milk. Do not breastfeed during treatment with VENCLEXTA.
What should I avoid while taking VENCLEXTA?

You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood.

What are the possible side effects of VENCLEXTA?

VENCLEXTA can cause serious side effects, including:

Low white blood cell counts (neutropenia). Low white blood cell counts are common with VENCLEXTA, but can also be severe. Your healthcare provider will do blood tests to check your blood counts during treatment with VENCLEXTA.
Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with VENCLEXTA. Your healthcare provider will closely monitor and treat you right away if you have a fever or any signs of infection during treatment with VENCLEXTA.
Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with VENCLEXTA.

The most common side effects of VENCLEXTA when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell counts; low platelet counts; low red blood cell counts; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of your arms, legs, hands, and feet.

The most common side effects of VENCLEXTA in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include low white blood cell counts; nausea; diarrhea; low platelet counts; constipation; fever with low white blood cell counts; low red blood cell counts; infection in blood; rash; dizziness; low blood pressure; fever; swelling of your arms, legs, hands, and feet; vomiting; tiredness; shortness of breath; bleeding; infection in lung; stomach (abdominal) pain; pain in muscles or back; cough; and sore throat.

VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of VENCLEXTA. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you cannot afford your medication, contact www.medicineassistancetool.org for assistance.

The full U.S. prescribing information, including Medication Guide, for VENCLEXTA can be found here.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie in Oncology
At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. AbbVie’s oncology portfolio now consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in more than 300 clinical trials and more than 20 different tumor types. For more information, please visit View Source