At 5:00 p.m. Eastern Time today, Gilead's management will host a conference call and a simultaneous webcast to discuss the transaction. A live webcast of the call can be accessed at Gilead’s Investors page at investors.gilead.com. Please connect to the website at least 15 minutes prior to the start of the call to allow adequate time for any software download that may be required. Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393 (international) and dial the conference ID 5776009 to access the call.
Telephone replay will be available approximately two hours after the call through 8:00 p.m. Eastern Time, September 15, 2020. To access the replay, please call 855-859-2056 (U.S.) or 404-537-3406 (international) and dial the conference ID 5776009. The webcast will be archived on www.gilead.com for one year.
Trodelvy (sacituzumab govitecan-hziy) is a Trop-2 directed antibody-drug conjugate indicated for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. To learn more about TRODELVYTM (sacituzumab govitecan-hziy), please visit www.trodelvy.com.
Trodelvy carries a black box warning for severe neutropenia and severe diarrhea. The most common adverse reactions occurring in 25 or more percent of patients included nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, decreased appetite, rash and abdominal pain. The most common Grade 3 or 4 adverse events occurring in more than 5 percent of patients were neutropenia, white blood cell count decreased, anemia, hypophosphatemia, diarrhea, fatigue, nausea and vomiting. Two percent of patients discontinued treatment due to adverse events. There were no deaths related to treatment and no severe cases of neuropathy or interstitial lung disease. See trodelvy.com for additional U.S. important safety information and full Prescribing Information, including Boxed Warning.
Immunomedics is a leader in next-generation antibody-drug conjugate (ADC) technology, committed to help transform the lives of people with hard-to-treat cancers. The company’s proprietary ADC platform centers on using a novel linker that does not require an enzyme to release the payload to deliver an active drug inside the tumor cell and the tumor microenvironment, thereby producing a bystander effect. Trodelvy, the company’s lead ADC, is the first ADC the FDA has approved for the treatment of people with metastatic triple-negative breast cancer and is also the first FDA-approved anti-Trop-2 ADC. For additional information on the Company, please visit its website at www.immunomedics.com. The information on its website does not, however, form a part of this press release.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.
This communication contains forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, related to Gilea
Compelling Strategic Benefits
Rapidly Expanding Trodelvy’s Benefit for Patients Globally: After closing Gilead intends to initiate numerous additional mid- and late-stage studies in the near term to determine which patients will benefit from Trodelvy as both a monotherapy or in combination with other products. Gilead brings commercial, medical, regulatory and manufacturing expertise, which will help rapidly advance Trodelvy through development and reach additional patients. Gilead will also bring to Immunomedics an established infrastructure and operations in Europe and Japan to support the launch of Trodelvy in those regions, pending approval. After closing, Gilead will retain global rights to Trodelvy outside of greater China, South Korea and certain Southeast Asian countries.
Trodelvy is Foundational to Gilead’s Oncology Franchise: Trodelvy will bring to Gilead a cornerstone product that broadens and deepens the company’s solid tumor pipeline, building on current marketed products and late-stage clinical candidates for patients with hematological malignancies at Kite and Gilead, including Yescarta®, Tecartus® and magrolimab.
Trodelvy is approved as a third-line treatment for mTNBC and has shown promise for earlier stages of the disease. TNBC represents approximately 15 to 20 percent of all breast cancer cases and is generally considered the most aggressive form of breast cancer. HR+/HER2- breast cancer accounts for more than 70 percent of all breast cancers.
Accelerates Gilead’s Revenue and EPS Growth: Trodelvy was launched in May of 2020 and has significant commercial potential in mTNBC and other solid tumors. In addition to immediately accelerating Gilead’s revenue growth, the acquisition of Immunomedics is expected to be neutral to accretive to Gilead’s non-GAAP EPS in 2023 and significantly accretive thereafter.
Transaction Terms and Financing
Under the terms of the merger agreement, a wholly-owned subsidiary of Gilead will promptly commence a tender offer to acquire all of the outstanding shares of Immunomedics’ common stock. The $88.00 per share acquisition price represents a 108 percent premium to Immunomedics’ closing price on September 11, 2020. Following successful completion of the tender offer, Gilead will acquire all remaining shares not tendered in the offer through a second step merger at the same price as the tender offer.
The consummation of the tender offer is subject to various conditions, including a minimum tender of at least a majority of outstanding Immunomedics shares, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions.
The tender offer is not subject to a financing condition and will be funded through approximately $15 billion in cash on hand, as well as approximately $6 billion in newly issued debt. Gilead expects to retain an investment grade credit rating following this transaction and this agreement does not alter Gilead’s stated capital allocation strategy or its commitment to maintain and grow its dividend over time.
Lazard and Morgan Stanley & Co. LLC are acting as financial advisors to Gilead. Centerview Partners LLC and BofA Securities are acting as financial advisors to Immunomedics. Cowen & Company, LLC also provided advice to Immunomedics. Davis Polk & Wardwell LLP is serving as legal counsel to Gilead and Watchell, Lipton, Rosen & Katz is serving as legal counsel to Immunomedics.
Buy the dip in biotechs - RBC
Sep. 21, 2020 3:34 PM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor
In a note RBC regards yesterday's selloff in biotechs as an "especially attractive entry point" for leading names such names as Gilead Sciences (GILD -2.1%), Sarepta Therapeutics (SRPT -1.8%) and Constellation Pharmaceuticals (CNST -5.0%).
Analysts, led by Brian Abrahams, believe GILD could head back toward the $80s citing its "increasingly cohesive" oncology strategy and potential upside on breast cancer antibody-drug conjugate Trodelvy (sacituzumab govitecan-hziy).
RBC remains a "believer" in SRPT's DMD gene therapies, looking forward to microdystrophin data in Q1 2021.
CNST does not reflect the "degree of de-risking" or long-term upside for lead BET inhibitor CPI-0610 which may improve upon Incyte's (INCY -2.2%) Jakafi (ruxolitinib) in myelofibrosis.
GILD, SRPT and CNST are 26%, 19% and 65%, respectively, off their 52-week highs.
Blijkbaar toch wel een goede move ondanks de prijs
U.K. to host first human challenge studies for COVID-19 vaccines
Sep. 23, 2020 10:08 AM ET|About: Gilead Sciences, Inc. (GILD)|By: Douglas W. House, SA News Editor
The Financial Times reports that the U.K. will host the world's first human COVID-19 challenge trials, in which healthy volunteers are deliberately infected with coronavirus, in order to evaluate the effectiveness of experimental vaccines.
The government-funded studies should launch in January 2021 at a 24-bed secure quarantine facility in east London.
About 2,000 potential U.K. volunteers have signed up through an advocacy group called 1Day Sooner which campaigns for COVID-19 infection trials aimed at accelerating development which are most useful when the viral infection rate is low. About 37K people globally have enlisted.
The group is launching a campaign this week to petition parliament for funds for a biocontainment facility with sufficient capacity to quarantine up to 200 people.
Volunteers will receive up to £3,750 for participating but may earn more considering the length of isolation, potentially as long as a month.
One key aspect of the studies is to select and purify a strain of the coronavirus that generally represents the SARS-CoV-2 strain currently circulating in the overall population.
Also, investigators will have a rescue remedy on hand to prevent serious illness in subjects. The London trial will initially use Gilead Sciences' (GILD +0.3%) Veklury (remdesivir).
In the U.S., NIH has awarded a $3.6M contract to Colorado State University to support the manufacture of two coronavirus strains that could be used in challenge studies. NIH is currently investigating the technical and ethical aspects for such trials.
Selected tickers: Johnson & Johnson (JNJ +1.0%), Moderna (MRNA -3.3%), Pfizer (PFE -0.1%), BioNTech SE (BNTX -3.6%), Sanofi (SNY +1.4%), GlaxoSmithKline (GSK +1.0%), AstraZeneca (AZN +1.4%)
Gilead's Jyseleca Ok'd in Japan for rheumatoid arthritis
Sep. 25, 2020 6:27 AM ET|About: Galapagos NV (GLPG)|By: Vandana Singh, SA News Editor
Japan's Ministry of Health, Labor and Welfare has approve Gilead's (NASDAQ:GILD) Jyseleca (filgotinib 200 mg and 100 mg tablets), a once-daily, oral, JAK1 inhibitor for the treatment of rheumatoid arthritis (RA) who did not respond to conventional therapies.
Gilead will hold the marketing authorization of Jyseleca in Japan and supply the product, while Eisai (OTCPK:ESALF) will manage distribution.
Gilead is developing Jyseleca in collaboration with Galapagos (NASDAQ:GLPG).
Last month, Galapagos and Gilead announced FDA CRL for filgotinib for RA as the agency requested for more data and review period extended into 2021.
Teva launches first generic versions of HIV-1 treatments in U.S.
Oct. 2, 2020 8:29 AM ET|About: Teva Pharmaceutical Indust... (TEVA)|By: Mamta Mayani, SA News Editor
Teva Pharmaceuticals (NYSE:TEVA) announces the availability of the first FDA-approved generic versions of Gilead Sciences' (NASDAQ:GILD) TRUVADA (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) and ATRIPLA (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) tablets.
These newly available generic medicines are indicated for the treatment of HIV-1 infection or HIV-1 pre-exposure prophylaxis when used alone or in combination with other anti-HIV-1 medicines.
Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are expected to be available at $48.51 per tablet.
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets will be available at a price of $78.86/tablet.
Shares are down 2% premarket.
Gilead voorbeurs flinke plus van 4,18%
Gilead and Galapagos's filgotinib shows sustained efficacy in ulcerative colitis study
Oct. 12, 2020 10:30 AM ET|About: Gilead Sciences, Inc. (GILD)|By: Vandana Singh, SA News Editor
Additional data from Phase 2b/3 Selection trial evaluating filgotinib in 1,348 biologic-naïve or biologic-experienced for the treatment of moderate to severe active ulcerative colitis (UC) patients, demonstrated sustained efficacy and safety. Results were presented at the 2020 United European Gastroenterology Week Virtual Meeting.
Gilead Sciences (GILD +0.3%) and Galapagos (GLPG +1.2%) have collaborated for the development filgotinib, an oral, once-daily, JAK1 preferential inhibitor.
Data showed that a significantly higher proportion of patients treated with filgotinib 200 mg, versus placebo, achieved clinical remission at Week 10 (26.1% vs. 15.3%).
Additionally, 24.5% of the patients treated with filgotinib 200 mg achieved Mayo Clinic Score remission, vs. 12.4% on placebo, endoscopic remission was seen in 12.2% of patients vs. 3.6% and histologic remission of 35.1% vs. 16.1%.
At Week 58, 37.2% of patients receiving filgotinib 200 mg achieved clinical remission, compared with 11.2% on placebo. Sustained clinical remission was observed at 18.1% vs. 5.1% placebo.
Also, 27.2% of patients treated with filgotinib 200 mg achieved six-month corticosteroid-free clinical remission at Week 58 compared with 6.4% in placebo.
On the safety front, incidence of adverse events (AE), serious AEs and discontinuations due to AEs were similar in the filgotinib and placebo groups in both the induction and maintenance periods of the study.
Most common adverse events of serious infections, herpes zoster, venous thrombosis, pulmonary embolism and gastrointestinal perforation, were observed.
Two deaths were observed in the filgotinib 200 mg maintenance arm, though those were considered unrelated to study drug, by the investigators.
Earlier in May, the companies announced that the study met the primary endpoints of statistically significant proportions of treated patients achieving remission at week 10 and maintaining remission at week 58, both compared to placebo.
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