On July 28, 2022 Takeda reported away from a cancer prospect it picked up in a $120 million deal (Press release, Takeda, JUL 28, 2022, View Source [SID1234617124]). In a pipeline clear-out (PDF) that also hit narcolepsy candidate TAK-994, the Japanese drugmaker revealed it has returned the rights to oncolytic virus TAK-605 to Turnstone Biologics just 31 months after inking a deal for the drug.

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Turnstone struck its deal in late 2019 with Takeda, which paid $120 million to co-develop RIVAL-01, also known as TBio-6517 and TAK-605, and enter into a discovery collaboration. The next year, the partners moved RIVAL-01 into a phase 1/2 Keytruda combination trial to assess the effect of intratumoral and intravenous doses of the oncolytic virus on solid tumor patients.

Now, Takeda has dropped the candidate, according to its quarterly financial report. Citing "strategic reasons," the company has terminated the collaboration and returned the global rights for the asset to Turnstone. The companies will continue to collaborate on the discovery of new candidates using Turnstone’s platform.

Takeda’s deal with Turnstone was part of a wave of interest in oncolytic viruses. With immunotherapies such as Keytruda proving ineffective in patients with "cold" tumors, Takeda and other companies zeroed in on oncolytic viruses as a way to turn tumors "hot" and thereby enable more people to benefit from checkpoint inhibitors.

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Turnstone teams up with Takeda in $900M deal to work on biotech’s oncolytic drug
Takeda disclosed news of the termination of the collaboration alongside other updates to its pipeline, including the confirmation of the demise of TAK-994. The company stopped two phase 2 trials of the oral orexin agonist, which was designed to increase wakefulness in narcolepsy patients, last year in response to a safety signal. At that time, Takeda said it would evaluate the data before deciding on the next steps.

The assessment of the benefit-risk profile led Takeda to opt against further development of TAK-994. Instead, the company will shift its attention to its orexin-2 receptor agonists TAK-861 and TAK-925. The continuation of work on the two phase 1 candidates suggests Takeda thinks the safety signal is specific to TAK-994 rather than a classwide problem.

Takeda also removed phase 1 Clostridium difficile infection candidate TAK-039 from its pipeline. The company called the action a "strategic decision" intended to "further optimize the portfolio."

On July 28, 2022 Novavax reported that Stanley C. Erck, President and Chief Executive Officer, Novavax, has been appointed by U.S. Secretary of Commerce Gina Raimondo to the U.S.-India CEO Forum (Forum) which brings together top-level business executives to discuss ways to strengthen the economic and commercial ties between the two countries, and to communicate their joint recommendations to the U.S. and Indian governments (Press release, Novavax, JUL 28, 2022, View Source [SID1234617143]).

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This appointment will provide Novavax’ CEO with the opportunity to lend insights based on his background of working extensively with some of India’s top business leaders. Further, Novavax will be a contributing partner in strengthening U.S. relationships with leaders in India and in a wide range of industries.

Established in 2005, the U.S.-India CEO Forum also informs government-to-government discussions, such as the U.S.-India Commercial Dialogue, on commercial affairs and highlights the strategic importance of the bilateral relationship.

On July 28, 2022 Labcorp (NYSE: LH), a leading global life sciences company, reported results for the second quarter ended June 30, 2022, and updated full-year guidance (Press release, LabCorp, JUL 28, 2022, View Source [SID1234617057]).

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"Labcorp continued to execute well during the second quarter," said Adam Schechter, chairman and CEO of Labcorp. "We remained dedicated to providing customers with the highest quality science and service while overcoming inflationary and macroeconomic challenges through our accelerated LaunchPad efforts. We also made significant progress against our strategy and reported plans to spin-off our Clinical Development business, resulting in two independent businesses poised for strong, sustainable growth."

Labcorp introduced several innovative diagnostics in the quarter and expanded its drug development capabilities to serve customers in Europe, the Middle East, Africa and Japan. Through Labcorp OnDemand, the company launched at-home collection kits for diabetes, men’s fertility, and for COVID-19, flu and RSV. Labcorp also made available a new skin cancer test for physicians that can also be used during clinical trials. And in July, the company began offering a test to help physicians diagnose conditions including concussions, Alzheimer’s and Parkinson’s.

Furthering its commitment to the fight against COVID-19, Labcorp maintained adequate capacity for current and future testing needs while providing innovations to assist in pandemic response efforts. To help address the monkeypox outbreak, the company collaborated with the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration to bring the CDC’s test to doctors and hospitals across the United States.

The company also advanced important strategic partnerships and acquisitions during the quarter, and its previously announced arrangement with Ascension is progressing through normal regulatory approvals.

On July 14, 2022, the company announced a quarterly cash dividend of $0.72 per share of common stock, payable on September 9, 2022, to stockholders of record at the close of business on August 18, 2022.

Spin-Off of the Clinical Development Business

In a separate press release issued this morning, Labcorp announced that its Board of Directors has authorized the company to pursue a spin-off of the company’s wholly owned Clinical Development business to Labcorp shareholders through a tax-free transaction. The spin-off will result in two independent, publicly traded companies, each poised for sustainable growth:

Labcorp: A leading global laboratory services business comprising the company’s routine and esoteric labs, central labs and early development research labs, all of which are leaders with deep scientific expertise, vast health data and insights, and an extensive, advanced global laboratory network.
The Clinical Development Business: A leading, global Contract Research Organization (CRO) providing Phase I-IV clinical trial management, market access and technology solutions to pharmaceutical and biotechnology organizations.
Labcorp is targeting completion of the planned spin-off in the second half of 2023. Labcorp leadership will discuss the planned spin-off in further detail on the company’s conference call today at 9:00 a.m. ET.

Consolidated Results

Second Quarter Results

Revenue for the quarter was $3.70 billion, a decrease of (3.7%) from $3.84 billion in the second quarter of 2021. The decrease was due to organic revenue of (3.4%) and foreign currency translation of (1.1%), partially offset by acquisitions net of divestitures of 0.8%. The (3.4%) decrease in organic revenue was driven by a (4.8%) decrease in COVID-19 PCR and antibody testing (COVID-19 Testing), partially offset by a 1.4% increase in the company’s organic Base Business. Base Business includes Labcorp’s operations except for COVID-19 Testing.

Operating income for the quarter was $525.9 million, or 14.2% of revenue, compared to $704.1 million, or 18.3%, in the second quarter of 2021. The company recorded amortization, restructuring charges, and special items, which together totaled $130.2 million in the quarter, compared to $135.8 million during the same period in 2021. Adjusted operating income (excluding amortization, restructuring charges, and special items) for the quarter was $656.1 million, or 17.7% of revenue, compared to $839.9 million, or 21.9%, in the second quarter of 2021. The decrease in operating income and margin was primarily due to a reduction in COVID-19 Testing, higher personnel expense, and other inflationary costs, partially offset by organic Base Business growth and LaunchPad savings.

Net earnings for the quarter were $358.6 million compared to $467.4 million in the second quarter of 2021. Diluted EPS were $3.87 in the quarter compared to $4.76 during the same period in 2021. Adjusted EPS (excluding amortization, restructuring charges, and special items) were $4.96 in the quarter compared to $6.13 in the second quarter of 2021.

Operating cash flow for the quarter was $572.5 million compared to $487.2 million in the second quarter of 2021. The increase in operating cash flow was due to higher cash earnings and favorable working capital. Capital expenditures totaled $143.3 million compared to $97.2 million a year ago. As a result, free cash flow (operating cash flow less capital expenditures) was $429.2 million compared to $390.0 million in the second quarter of 2021.

At the end of the quarter, the company’s cash balance and total debt were $1.1 billion and $5.4 billion, respectively. During the quarter, the company invested $99.8 million on acquisitions, paid out $66.7 million in dividends, and repurchased $400.0 million of stock representing approximately 1.7 million shares.

Year-To-Date Results

Revenue was $7.6 billion, a decrease of (5.1)% from $8.0 billion, in the first six months of 2022. The decrease was due to lower organic revenue of (4.9%) and foreign currency translation of (0.7%), partially offset by acquisitions net of divestitures of 0.6%. The (4.9%) decrease in organic revenue was a (7.4%) decrease in COVID-19 Testing, partially offset by a 2.5% increase in the Company’s organic Base Business.

Operating income was $1,213.8 million, or 16.0% of revenue, compared to $1,762.0 million, or 22.0%, in the first six months of 2021. The company recorded amortization, restructuring charges, special items, and impairments, which together totaled $236.3 million in the first six months of 2022 compared to $259.8 million during the same period in 2021. Adjusted operating income (excluding amortization, restructuring charges, special items, and impairments) was $1,450.1 million, or 19.1% of revenue, compared to $2,021.8 million, or 25.3%, in the first six months of 2021. The decrease in operating income and margin was primarily due to lower COVID-19 Testing and higher personnel costs, partially offset by a recovery in the Base Business.

Net earnings were $850.2 million compared to $1,237.0 million in the first six months of 2021. Diluted EPS were $9.11 in the first six months of 2022 compared to $12.58 during the same period in 2021. Adjusted EPS (excluding amortization, restructuring charges, special items, and impairments) were $11.07 in the first six months of 2022 compared to $14.92 during the same period in 2021.

Operating cash flow was $928.5 million compared to $1,644.8 million in the first six months of 2021. The decrease in operating cash flow was due to lower cash earnings and unfavorable working capital. Capital expenditures totaled $260.5 million compared to $192.6 million during the same period in 2021. As a result, free cash flow (operating cash flow less capital expenditures) was $668.0 million compared to $1,452.2 million in the first six months of 2021.

Second Quarter Segment Results

The following segment results exclude amortization, restructuring charges, special items, and unallocated corporate expenses.

Diagnostics

Revenue for the quarter was $2.26 billion, a decrease of (4.7%) from $2.37 billion in the second quarter of 2021. The decrease was primarily due to organic revenue of (5.7%), partially offset by acquisitions of 1.2%. The (5.7%) decrease in organic revenue was due to a (7.8%) decrease in COVID-19 Testing, partially offset by a 2.1% increase in the Base Business. Total Base Business growth compared to the Base Business in the prior year was 3.9%.

Total volume (measured by requisitions) decreased by (2.7%) as organic volume decreased by (3.1%) and acquisition volume contributed 0.4%. Organic volume was impacted by a (5.6%) decrease in COVID-19 Testing, partially offset by a 2.6% increase in Base Business. Price/mix decreased by (2.0%) due to a decrease in COVID-19 Testing of (2.2%) and a decline in organic Base Business of (0.4%), partially offset by acquisitions of 0.8%. Base Business volume was up 3.4% compared to the Base Business last year, while price/mix was up 0.5%.

Adjusted operating income for the quarter was $515.6 million, or 22.9% of revenue, compared to $663.2 million, or 28.0%, in the second quarter of 2021. The decrease in adjusted operating income and adjusted operating margin was primarily due to a reduction in COVID-19 Testing, higher personnel expense, and other inflationary costs, partially offset by organic Base Business growth and LaunchPad savings.

Drug Development

Revenue for the quarter was $1.45 billion, a decrease of (2.9)% from $1.50 billion in the second quarter of 2021. The decrease was due to foreign currency translation of (2.6%) and lower COVID-19 Testing of (0.6%), partially offset by acquisitions net of divestitures of 0.2% and organic Base Business growth of 0.1%. Organic Base Business growth was impacted by reduced COVID-19 related work, the Ukraine/Russia crisis, and lower pass-throughs.

Adjusted operating income for the quarter was $213.3 million, or 14.7% of revenue, compared to $221.1 million, or 14.8%, in the second quarter of 2021. Adjusted operating income and margin decreased primarily due to COVID-19 Testing, a reduction in COVID-19 related work, the Ukraine/Russia crisis, and inflationary costs. These impacts were partially offset by organic Base Business growth and LaunchPad savings. In addition, personnel expense was lower due to cost reduction actions and variable compensation.

Net orders and net book-to-bill during the trailing twelve months were $7.15 billion and 1.23, respectively. Backlog at the end of the quarter was $15.21 billion, an increase of 6.5% compared to last year. The company expects approximately $4.84 billion of its backlog to convert into revenue in the next twelve months.

Outlook for 2022

Labcorp is updating 2022 full year guidance to reflect its second quarter performance and full-year outlook. The following guidance assumes foreign exchange rates effective as of June 30, 2022, for the remainder of the year. Enterprise level guidance includes the estimated impact from currently anticipated capital allocation, including acquisitions, share repurchases and dividends.

Use of Adjusted Measures

The company has provided in this press release and accompanying tables "adjusted" financial information that has not been prepared in accordance with GAAP, including adjusted net income, adjusted EPS (or adjusted net income per share), adjusted operating income, adjusted operating margin, free cash flow, and certain segment information. The company believes these adjusted measures are useful to investors as a supplement to, but not as a substitute for, GAAP measures, in evaluating the company’s operational performance. The company further believes that the use of these non-GAAP financial measures provides an additional tool for investors in evaluating operating results and trends, and growth and shareholder returns, as well as in comparing the company’s financial results with the financial results of other companies. However, the company notes that these adjusted measures may be different from and not directly comparable to the measures presented by other companies. Reconciliations of these non-GAAP measures to the most comparable GAAP measures and an identification of the components that comprise "special items" used for certain adjusted financial information are included in the tables accompanying this press release.

The company today is providing an investor relations presentation with additional information on its business and operations, which is available in the investor relations section of the company’s website at View Source Analysts and investors are directed to the website to review this supplemental information.

A conference call discussing Labcorp’s quarterly results will be held today at 9:00 a.m. ET and is available by dialing 800-715-9871 (646-307-1963 for international callers). The conference ID is 4124787. A telephone replay of the call will be available through August 11, 2022, and can be heard by dialing 800-770-2030 (609-800-9909 for international callers). The conference ID for the replay is 4124787. A live online broadcast of Labcorp’s quarterly conference call on July 28, 2022, will be available at Labcorp Investor Relations website beginning at 9:00 a.m. ET. This online broadcast will be archived and accessible through July 14, 2023.

On July 28, 2022 ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, and the Medicines Patent Pool (MPP) reported the signing of a new voluntary licensing agreement for patents relating to cabotegravir long-acting (LA) for HIV pre-exposure prophylaxis (PrEP) to help enable access in least developed, low-income, lower middle-income and Sub-Saharan African countries1,2 (Press release, GlaxoSmithKline, JUL 28, 2022, View Source [SID1234617074]).

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Through this agreement, selected generic manufacturers will have the opportunity to develop, manufacture and supply generic versions of cabotegravir LA for PrEP, the first long-acting HIV prevention medicine, in 90 countries, subject to required regulatory approvals being obtained. It is expected that this agreement will help to enable at-scale access to generic cabotegravir LA for PrEP. This announcement comes just seven months after the first regulatory approval of cabotegravir LA for PrEP in the world, by the US Food and Drug Administration (US FDA).

Each year, there are approximately 1.5 million new cases of HIV worldwide3, most of which occur in resource-limited countries, with women and adolescent girls disproportionately impacted. While oral PrEP options are available in many countries, challenges with adherence and stigma have limited their impact in some populations. Access to an effective long-acting HIV prevention option could significantly contribute towards the goal of ending the epidemic.

The new voluntary licence announced today builds on a long-standing partnership between ViiV Healthcare and MPP, which has been highly successful in facilitating the manufacture and sale of generic versions of oral ViiV Healthcare medicines in countries most affected by HIV and least able to pay for treatment and care. In particular, voluntary licensing has enabled access to generic products containing another of ViiV Healthcare’s innovative medicines, dolutegravir, for at least 20 million people living with HIV in low- and middle-income countries, as of December 20214.

Deborah Waterhouse, CEO at ViiV Healthcare said, "Today’s announcement represents a potentially game-changing moment in HIV prevention. Enabling at-scale access to generic cabotegravir LA for PrEP could play a significant role in averting the transmission of HIV, particularly amongst women and adolescent girls and help end the HIV epidemic. I am proud that through our long-standing partnership with MPP, we continue to play our part in widening access for people in resource-limited countries to new innovative medicines."

Charles Gore, MPP Executive Director said, "We are delighted to sign this voluntary licence with ViiV for cabotegravir LA for PrEP. Long-acting technologies open up a whole new dimension that facilitates medicine uptake, and this product brings a much-needed option for those at risk. This licence was negotiated in double-quick time and is another example of MPP’s continued commitment to making innovation available and affordable in low- and lower middle-income countries in the shortest possible time. Rapid access to new technologies is our only hope of hitting the Sustainable Development Goal targets."

This voluntary licence forms part of a holistic approach to enable at-scale access to cabotegravir LA for PrEP in least developed, low-income, lower middle-income and Sub-Saharan African countries1. There are complexities and considerations that need to be managed to support the manufacturing and roll out of a generic long-acting injectable. Compared to oral PrEP options, cabotegravir LA for PrEP is more complex to manufacture and there is an evolving and less well-defined demand for the product. These are challenges not only for ViiV but also for any potential generic partners. ViiV Healthcare and MPP will now work closely with stakeholders and generic manufacturers selected through MPP’s expression of interest to enable access to generic cabotegravir LA for PrEP as soon as possible.

Cabotegravir LA for PrEP is a long-acting injectable which has recently gained its first regulatory approval for use in HIV prevention in the USA for at risk adults and adolescents weighing at least 35kg for PrEP to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test prior to receiving it. It is not currently approved for use in HIV prevention anywhere outside of the USA. ViiV Healthcare has submitted marketing applications in a number of countries including the majority of countries where the clinical trials were conducted, with further registrations planned. ViiV Healthcare is also working with stakeholders including global health agencies, non-governmental organisations (NGOs), governments and community partners to understand country-specific contexts and is supporting implementation science projects that will provide critical information on the feasibility, acceptability and scalability to deliver successful introduction of cabotegravir LA for PrEP into national programmes.

Partner quotes:

"Long-acting PrEP has the potential to transform HIV prevention efforts, but only if it is made widely available at affordable prices. Unitaid welcomes the news of this voluntary licence, agreed in record time, which gives people at risk of infection additional options so they can choose the HIV prevention method that works for them. Developing solutions that respond to different needs and preferences is critical to averting new infections globally."

Dr Philippe Duneton, Executive Director, Unitaid

Unitaid created the MPP to facilitate access conditions for critical medicines in 2010 and continues to be MPP’s principal funder. A new coalition to accelerate access to long-acting PrEP, convened by Unitaid and partners, is working to develop and implement coordinated strategies to overcome access challenges to new PrEP options.

"This is really welcome news and a next important step along the road to ensuring the promising innovation of injectable cabotegravir LA for PrEP is made accessible to all who would benefit from it even those from the least well-resourced regions. We know primary prevention is key to controlling HIV globally but to get the most from innovation we need access and scale up."

Linda-Gail Bekker, Director of the Desmond Tutu HIV Centre at the University of Cape Town

Indication and Important Safety Information for Apretude (cabotegravir extended-release injectable suspensions)

APRETUDE is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION

Individuals must be tested for HIV-1 infection prior to initiating APRETUDE or oral cabotegravir, and with each subsequent injection of APRETUDE, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE for HIV-1 PrEP unless negative infection status is confirmed. Individuals who become infected with HIV-1 while receiving APRETUDE for PrEP must transition to a complete HIV-1 treatment regimen.

CONTRAINDICATIONS

Do not use APRETUDE in individuals:
with unknown or positive HIV-1 status
with previous hypersensitivity reaction to cabotegravir
receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, and rifapentine
WARNINGS AND PRECAUTIONS

Comprehensive Management to Reduce the Risk of HIV-1 Infection:

Use APRETUDE as part of a comprehensive prevention strategy, including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). APRETUDE is not always effective in preventing HIV-1 acquisition. Risk for HIV-1 acquisition includes, but is not limited to, condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network. Inform, counsel, and support individuals on the use of other prevention measures (e.g., consistent and correct condom use; knowledge of partner[s] HIV-1 status, including viral suppression status; regular testing for STIs)
Use APRETUDE only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only APRETUDE, because APRETUDE alone does not constitute a complete regimen for HIV-1 treatment. Prior to initiating APRETUDE, ask seronegative individuals about recent (in past month) potential exposure events and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash). If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection
When using APRETUDE, HIV-1 testing should be repeated prior to each injection and upon diagnosis of any other STIs
Additional HIV testing to determine HIV status is needed if an HIV-1 test indicates possible HIV-1 infection or if symptoms consistent with acute HIV-1 infection develop following an exposure event. If HIV-1 infection is confirmed, then transition the individual to a complete HIV-1 treatment
Counsel HIV-1 uninfected individuals to strictly adhere to the recommended dosing and testing schedule for APRETUDE
Potential Risk of Resistance with APRETUDE:

There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE. To minimize this risk, it is essential to clinically reassess individuals for risk of HIV-1 acquisition and to test before each injection to confirm HIV-1–negative status. Individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment. If individuals at continuing risk of HIV-1 acquisition discontinue APRETUDE, alternative forms of PrEP should be considered and initiated within 2 months of the final injection of APRETUDE
Long-Acting Properties and Potential Associated Risks with APRETUDE:

Residual concentrations of cabotegravir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer). Take the prolonged-release characteristics of cabotegravir into consideration and carefully select individuals who agree to the required every-2-month injection dosing schedule because non-adherence or missed doses could lead to HIV-1 acquisition and development of resistance
Hypersensitivity Reactions:

Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with APRETUDE
Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated
Hepatotoxicity:

Hepatotoxicity has been reported in a limited number of individuals receiving cabotegravir with or without known pre-existing hepatic disease or identifiable risk factors
Clinical and laboratory monitoring should be considered and APRETUDE should be discontinued if hepatotoxicity is suspected and individuals managed as clinically indicated
Depressive Disorders:

Depressive disorders (including depression, depressed mood, major depression, persistent depressive disorder, suicidal ideation or attempt) have been reported with APRETUDE
Promptly evaluate patients with depressive symptoms
Risk of Reduced Drug Concentration of APRETUDE Due to Drug Interactions:

The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE
Refer to the full Prescribing Information for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE; review concomitant medications during use of APRETUDE
ADVERSE REACTIONS

The most common adverse reactions (incidence ≥1%, all grades) with APRETUDE were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, and upper respiratory tract infection.

DRUG INTERACTIONS

Refer to the full Prescribing Information for important drug interactions with APRETUDE
Drugs that induce UGT1A1 may significantly decrease the plasma concentrations of cabotegravir
USE IN SPECIFIC POPULATIONS

Lactation: Assess the benefit-risk of using APRETUDE to the infant while breastfeeding due to the potential for adverse reactions and residual concentrations in the systemic circulation for up to 12 months or longer after discontinuation
Pediatrics: Not recommended in individuals weighing less than 35 kg
About the Medicines Patent Pool

The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to, and facilitate the development of, life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups, and other stakeholders to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, MPP has signed agreements with 15 patent holders for thirteen HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, two long-acting technologies, two oral antiviral treatments for COVID-19 and 12 COVID-19 technologies. MPP was founded by Unitaid, which continues to be MPP’s main funder. MPP’s work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC). MPP’s activities in COVID-19 are undertaken with the financial support of the Japanese Government, the French Ministry for Europe and Foreign Affairs and SDC.

On July 28, 2022 Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to synthetic biology, reported the Company will release its second quarter 2022 financial results before the market opens on Thursday, August 11, 2022 (Press release, Synlogic, JUL 28, 2022, View Source [SID1234617090]). The press release will be followed by a conference call at 8:30 A.M. ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review its financial results and provide a business update.

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To access the webcast, please register here. To access the call by phone, please register here and you will be provided with dial in details. You can also access these links on the "Events Calendar" section of the Investors & Media webpage. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Company’s website.