Piper Jaffray analyst Sarah James downgraded Aetna to Neutral and lowered her price target to $206 from $212.
Wednesday, October 31, 2018
Tuesday, October 30, 2018
ViiV: positive data for long-acting injectable HIV-1 med
ViiV Healthcare reports positive 48-week results for second phase III study for novel, long-acting, injectable HIV-treatment regimen
FLAIR study meets primary endpoint, showing similar efficacy of a once-a-month, investigational, injectable two-drug regimen of cabotegravir and rilpivirine compared to a daily, oral three-drug, integrase-based regimen in virally-suppressed adults
London, 30 October 2018- ViiV Healthcare today announced positive headline results from its global, Phase III FLAIR (First Long-Acting Injectable Regimen) study of a long-acting, injectable two-drug regimen (2DR) for the treatment of HIV. FLAIR was designed to study if adults infected with human immunodeficiency virus type-1 (HIV-1), whose virus is suppressed after 20 weeks on the daily, oral medicine Triumeq (abacavir/dolutegravir/lamivudine-ABC/DTG/3TC), remain suppressed at a similar rate to continuing Triumeq after switching to a monthly two-drug intramuscular long-acting injectable regimen of cabotegravir and rilpivirine.
The study showed long-acting cabotegravir and rilpivirine, injected once a month, had similar efficacy to Triumeq at Week 48 based on the proportion of participants with plasma HIV-1 RNA ≥50 copies per millilitre [c/mL] using the FDA Snapshot algorithm. Overall safety, virologic response and drug resistance results for the injectable regimen were consistent with results from the phase II LATTE and LATTE-2 studies.[1],[2]
John C. Pottage, Jr., MD, Chief Scientific and Medical Officer of ViiV Healthcare, said: ‘The FLAIR data provide further evidence that a long-acting, injectable 2DR of cabotegravir and rilpivirine may offer an alternative to daily, oral therapy for people who have previously achieved viral suppression. This innovative dosing regimen could transform HIV therapy by reducing the number of days a person receives treatment from 365 to 12. Work on new methods of HIV treatment, including long-acting injectable therapies, supports ourgoal of making HIV a smaller part of the lives of people living with HIV.’
Detailed results from the study will be presented at an upcoming scientific meeting.
FLAIR is ViiV Healthcare’s second, phase III clinical trial to examine the safety and efficacy of monthly dosing of injectable formulations of cabotegravir and rilpivirine. The ATLAS (Antiretroviral Therapy as Long Acting Suppression) study, for which positive headline data was reported in August, compares a long-acting, injectable regimen against the continuation of current daily oral antiretroviral therapy in virologically suppressed, treatment-experienced patients.[3] ViiV Healthcare plans to use pooled data from the FLAIR and ATLAS studies for future regulatory submissions.
This investigational, long-acting, injectable regimen is being co-developed as part of a collaboration with Janssen Sciences Ireland UC and is not approved by regulatory authorities anywhere in the world.
Illumina Launches TruSight Oncology 500 for Pan-Cancer Tumor Profiling
The newest addition to the Illumina oncology portfolio offers researchers the ability to measure Tumor Mutational Burden and Microsatellite Instability, and detect other known and emerging biomarkers
Illumina, Inc. (NASDAQ: ILMN) today announces the launch of TruSightTM Oncology 500 (TSO 500), a comprehensive pan-cancer assay designed to identify known and emerging tumor biomarkers. TruSight Oncology 500 utilizes both DNA and RNA from subject tumor samples to identify key somatic variants underlying tumor progression, such as small DNA variants, fusions, and splice variants. Importantly, TruSight Oncology 500 can measure tumor mutational burden (TMB) and microsatellite instability (MSI), features that are potentially key biomarkers for emerging immunotherapies. TruSight Oncology 500 is for research use only and will ship in Q1 2019.
Molecular testing in lung cancer has been at the forefront of precision oncology. The use of targeted therapies is associated with improved outcomes in some patients, and currently requires testing multiple biomarkers, such as EGFR mutations, ALK fusions, and ROS fusions, among others. Recently, TMB gained prominence as a biomarker that demonstrates better response and survival from immune checkpoint inhibitors in patients exhibiting high TMB, necessitating the need for comprehensive sequencing. Reliable measurement of TMB in a tumor-only workflow requires sequencing of approximately 1Mb or greater, specific and sensitive variant calling, as well as bioinformatic methods to flag and remove germline variants. Given the increasing number of biomarkers required to fully understand the optimal therapeutic course, assays like TruSight Oncology 500—one of the largest and most comprehensive panels to-date—encompasses all of these biomarkers, making it an ideal choice for cancer researchers today.
“The importance of tumor mutational burden as a biomarker to predict immune checkpoint inhibition response continues to grow in non-small cell lung cancer,” said Albrecht Stenzinger, MD, pathologist at University Hospital Heidelberg, Germany. “However, the detection of somatic biomarkers, such as ALK fusions and EGFR small variants, are also vital. The workflow of TSO 500, using both DNA and RNA, enables laboratories to evaluate TMB, as well as small DNA variants and fusions simultaneously, ultimately saving time and preserving precious samples.”
“While many methods are arising that measure TMB, these methods may differ in their variant calling performance and their gene content, affecting measurement,” said Dr. Carina Heydt, a molecular biologist at the University of Cologne, Institute of Pathology, in Germany. “As an early access site for TSO 500, not only did we find the assay easy to implement in our laboratory, but the enrichment-based chemistry of the assay, coupled with the novel bioinformatic pipeline, demonstrate a high-variant calling performance and reproducible TMB measurements.”
Pharmaceutical partners and payers are shifting toward deeper, broader sequencing to help predict which patients may benefit from new treatments including immunotherapies, targeted therapies and the many potential combinations. Recently, Bristol-Myers Squibb Company (NYSE: BMY) and Illumina announced a collaboration to develop and globally commercialize companion diagnostics, based on TruSight Oncology 500 content, to support Bristol-Myers Squibb’s oncology portfolio.
“By focusing on our most differentiated oncology products, we can meet the needs of our customers and provide a comprehensive NGS panel that includes all of the known and anticipated biomarkers associated with targeted and immune-based therapies,” said Garret Hampton, Executive Vice President of Clinical Genomics at Illumina. “As we move to bring a future in vitro diagnostic version through regulatory approval, we will be able to set the standard for accurate and reproducible testing. Today’s value in the capability to call for TMB is in line with current research and emerging guidelines, but the promise that TruSight Oncology 500 holds for the future identification of biomarkers, makes it a robust solution for this rapidly evolving field.”
Allergan: Offers undervalue business units for sale
Allergan Plc on Tuesday expressed disappointment in early offers from potential buyers for business units it has been trying to sell, and its shares fell more than 6 percent.
Allergan has been shopping its women’s health and infectious disease businesses since May, following a strategic review of the company undertaken in an effort to reverse a steep slide in its share price.
On call with analysts to discuss third quarter results, Chief Executive Officer Brent Saunders said early buyer interest for the units was below the price he believes they are worth.
“These are good businesses, right? We have always said that while we absolutely would like to sell these businesses, we need to make sure that we get the right price given the dilutive effect on a variety of our financial metrics,” Saunders said.
It was not immediately clear whether the interest was for the units as a whole or for certain parts.
Shares of the Dublin-based company fell 6.3 percent to $162.91, despite Allergan reporting higher-than-expected third quarter profit.
The Botox maker’s plans have been met with investor concerns, including from billionaire shareholder David Tepper’s Appaloosa Management, who had said he hoped for a more dramatic outcome from the strategic review.
Sales of Botox powered Allergan’s quarterly profit as it maintained dominance in the cosmetic wrinkle treatment market.
Overall Botox sales, which also include medical uses such as treating migraine headaches, jumped 13.6 percent to $879.7 million in the quarter, topping analysts estimates of $847.4 million, according to Refinitiv data.
Sales of the company’s dry eye drug, Restasis, fell 18.5 percent to $311.6 million in the quarter. But the decline was not as severe as some investors had feared due to a delay to market of cheaper generic versions of the treatment.
The company said it now expects full-year adjusted earnings of $16.20 to $16.60 per share, compared with its previous forecast of $16.00 to $16.50 per share. The company partly attributed the raise to the delay of Restasis generics.
Once a drug begins facing competition from multiple generic versions, it can quickly lose more than 80 percent of sales.
Excluding items, the company earned $4.25 per share, beating analysts’ average estimate by 21 cents, according to Refinitiv data.
Net revenue fell 3 percent to $3.91 billion.
AstraZeneca sells some rights to Nexium, Vimovo to Grunenthal
AstraZeneca said it would sell the European rights to acid-reflux medicine Nexium to Grunenthal for an upfront $700 million (£550.9 million) and future sales-related payments of up to $90 million as it is not in the company’s targeted therapy areas.
The British company said Grunenthal, a privately owned German company, would also buy the worldwide rights, excluding the United Sates and Japan, to pain-relief drug Vimovo for $115 million plus potential additional payments of up to $17 million.
Nexium, a proton pump inhibitor developed by AstraZeneca, has lost patent protection in the majority of global markets, while Vimovo is protected in most European markets until 2025.
The rights to over-the-counter Nexium were sold to Pfizer in 2012.
AstraZeneca said it would continue to manufacture and supply Nexium under a long-term supply agreement and will continue to commercialise the medicine in all markets outside Europe.
The pharmaceutical company is focusing on the three main therapy areas of oncology, cardiovascular, renal and metabolism and respiratory.
Exact Sciences Cologuard revenue up 63%, test volume +49% in Q3
Exact Sciences Corp. (Nasdaq: EXAS) today announced that the company generated revenue of $118.3 million and screened approximately 241,000 people with Cologuard during the quarter ended September 30, 2018. Third-quarter 2018 revenue and Cologuard test volume grew by 63 percent and 49 percent, respectively, from the same period of 2017.
“The Exact Sciences team delivered another strong quarter, highlighted by significantly increased patient access to Cologuard with no out-of-pocket cost and continued progress toward our 2018 priorities,” said Kevin Conroy, chairman and CEO of Exact Sciences. “We are enthusiastic about our partnership with Pfizer and launched Cologuard to their internal medicine team in early October. We look forward to working with such a tremendous partner in the fight against colon cancer.”
Third-Quarter 2018 Financial Results
For the three-month period ended September 30, 2018, as compared to the same period of 2017 (where applicable):
- Revenue was $118.3 million, an increase of 63 percent, and test volume was 241,000, an increase of 49 percent
- Average recognized revenue per test was $492, an improvement of 9 percent
- Average cost per test was $125, an improvement of 3 percent
- Gross margin was 75 percent, an increase of 320 basis points
- Operating expenses were $129.2 million, an increase of 61 percent
- Net loss was $45.4 million or $0.37 per share, compared to $26.9 million or $0.23per share
- Non-cash interest expense related to convertible debt was $8.4 million, or $0.07per share
- Cash utilization was $36.9 million, compared to $21.7 million
- Cash, cash equivalents and marketable securities were $1.2 billion at the end of the quarter
- More than 11,000 healthcare providers ordered their first Cologuard test during the third quarter, and nearly 132,000 have ordered since the test was launched
2018 Outlook
- The company anticipates revenue of $435–$440 million for 2018, an increase from prior guidance of $420–$430 million
The company’s guidance for revenue is a forward-looking statement. It is subject to various risks and uncertainties that could cause the company’s actual results to differ materially from the anticipated targets. There can be no assurance the company will meet these financial projections. See the cautionary information about forward-looking statements in the “Safe Harbor Statement” section of this press release.
Third-Quarter Conference Call & Webcast
Company management will host a conference call and webcast on Tuesday, Oct. 30, 2018, at 5 p.m. ET to discuss third-quarter 2018 results. The webcast will be available at www.exactsciences.com. Domestic callers should dial 877-201-0168 and international callers should dial +1-647-788-4901.
An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 6870368. The webcast, conference call and replay are open to all interested parties.
Genmab and J&J’s Darzalex Dazzles in Multiple Myeloma Trial
Denmark-based Genmab A/S released topline data from its Phase III MAIA trial of a drug it licensed to Johnson & Johnson’s Janssen, Darzalex (daratumumab). The drug is being evaluated in combination with Celgene’s Revlimid (lenalidomide) and dexamethasone (DRd), compared to Revlimid and dexamethasone alone in patients newly diagnosed with multiple myeloma who are not candidates for high-dose chemotherapy and autologous stem cell transplant.
The trial met its primary endpoint of improved progression-free survival (PFS) at a pre-planned interim analysis. There was a 45 percent decrease in the risk of progression or death in patients with Revlimid and dexamethasone (DRd). The median PFS for patients receiving Darzalex in combination with Rd wasn’t reached, compared to an estimated median PFS of 31.9 months for the patients who received Rd alone.
Based on the data, an Independent Data Monitoring Committee (IDMC) recommended Genmab release the interim data. Genmab will continue to analyze the safety and efficacy data. Janssen licensed Darzalex from Genmab in 2012. It plans to discuss submitting the combination to regulators, present the data at an upcoming medical conference and submit to a peer-reviewed journal.
Genmab licensed Darzalex to Janssen in 2012. Janssen has a worldwide license to develop, manufacture and commercialize Darzalex. There are ongoing trials for the drug, including multiple Phase III studies in smoldering, relapsed and frontline multiple myeloma settings and in amyloidosis. Janssen either has ongoing trials or plans studies to evaluate the drug in other malignant and pre-malignant diseases, including NKT-cell lymphoma, myelodysplastic syndrome, B and T-ALL.
Darzalex has received two Breakthrough Therapy Designations from the US. Food and Drug Administration (FDA) as a monotherapy and in combination with other therapies.
Darzalex is approved in the U.S. in combination with bortezomib, melphalan and prednisone to treat patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for second-line treatment for multiple myeloma; in combination with pomalidomide and dexamethasone as third-line multiple myeloma, and as a monotherapy for multiple myeloma patients who receive three previous therapies, including a protease inhibitor (PI) and an immunomodulatory agent, or who are double refractory to a PI, and an immunomodulatory agent who have shown disease progression on the last therapy.
“We are highly encouraged by this data as this is the fifth randomized study showing a profound benefit when adding daratumumab to standard of care treatments in multiple myeloma, and the second showing efficacy for patients with newly diagnosed multiple myeloma who are not eligible for ASCT,” said Jan van de Winkel, Genmab’s chief executive officer, in a statement. “As such, this data increases our hope that daratumumab may one day help even more patients at the outset of treatment of this disease.”
The results from this trial are good news. Darzalex had previously failed earlier-stage trials in combination with Roche’s PD-L1 inhibitor Tecentriq (atezolizumab) in non-small cell lung cancer, and with J&J’s PD-1 inhibitor JNJ-63723283 in multiple myeloma. Those trials were both terminated due to an increase in patient deaths.
In 2017, Darzalex brought in $1.24 billion, but van de Winkel has said that if it could get approval into other blood cancers and solid tumors, sales could top $9 billion.
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