Gilead Sciences announced that the China National Medical Products Administration has approved Descovy, a fixed-dose combination for the treatment of HIV. In China, Descovy is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 in adults and adolescents. In the United States, Descovy has a boxed warning in its product label regarding the risk of post treatment acute exacerbation of hepatitis B. TAF is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to Gilead’s TDF but at one-tenth of the dose. Data show that because TAF has greater plasma stability and more efficiently delivers tenofovir to peripheral blood mononuclear cells compared to TDF, it can be given at a lower dose, resulting in less tenofovir in the bloodstream. In clinical trials, TAF demonstrated improved renal and bone laboratory safety parameters compared to TDF. In 2017, there were 134,512 people newly diagnosed with HIV in China. The number of diagnoses has increased significantly in recent years, partially due to expanded screening. At the same time, the number of people living with HIV and receiving antiretroviral treatment has also increased steadily. The government of China has provided free antiretroviral treatment to all persons living with HIV since 2003. The approval of Descovy is supported by 144-week data from two pivotal Phase 3 studies in which the F/TAF-based regimen met its primary objective of non-inferiority compared to an F/TDF-based regimen among treatment naive adult patients. Tests of certain renal and bone laboratory parameters favored the F/TAF-based regimen over the F/TDF-based regimen. The approval also is supported by a Phase 3 study evaluating the F/TAF-based regimen among virologically suppressed adult patients who switched from F/TDF-based regimens. In the study, the F/TAF-based regimen was found to be statistically non-inferior to the F/TDF-based regimens and demonstrated improvements in certain bone and renal laboratory parameters compared to the F/TDF-based regimens. Additionally, the approval is supported by data from Phase 3 studies evaluating the F/TAF-based regimen among virologically suppressed adults with mild-to-moderate renal impairment and among treatment naive adolescents. Descovy received marketing approval from the U.S. Food and Drug Administration and the European Commission in 2016. In the U.S., only the emtricitabine 200 mg/tenofovir alafenamide 25 mg dosage form is approved. Descovy does not cure HIV infection or AIDS.
Tuesday, December 4, 2018
Seattle Genetics’ T-cell lymphoma data best case scenario, says William Blair
The “quality and robustness” of the data Seattle Genetics reported from the successful Phase III Ecehlon-2 study, which assesses the safety and efficacy of Adcetris plus a three-drug chemotherapy regimen versus the standard of care four-drug chemotherapy regimen in frontline mature T-cell lymphomas, represent the “best case scenario,” William Blair analyst Andy Hsieh tells investors in a research note. The analyst highlights that the indication was approved 11 days after Seattle Genetics submitted the regulatory application to the FDA, which took advantage of the Real-Time Oncology Review Program. He believes Adcetris will be “quickly adopted” in the frontline mature T-cell lymphoma setting, a $400M market in the United States alone. The analyst keeps an Outperform rating on the shares.
Clovis upgraded to Outperform after favorable EU patent ruling at Leerink
Leerink analyst Andrew Berens upgraded Clovis Oncology (CLVS) to Outperform from Market Perform after the European Patent Office upheld claims of a European patent on Rubraca. He said the finding of inventiveness in Europe strengthens his confidence in the U.S. patent estate and removes a near-term intellectual property overhang on Clovis shares. Berens now sees a 50% chance of branded exclusivity through 2023 in the U.S. in the “worst case” and through 2031 in the “best case.” He also said Glaxo’s (GSK) acquisition of competitor Tesaro (TSRO) brings a “return of optionality” to Clovis shares. Berens raised his price target on Clovis to $40 from $22.
Veeva slides after short-seller Citron puts $65 target on shares
Shares of Veeva Systems (VEEV) are under pressure after short-seller Citron Research said that market correction should hit the stock “harder than any other SaaS” peer and put a $65 price target on the shares. This morning, Leerink analyst David Larsen started coverage of Veeva with an Outperform rating and $120 price target. MARKET CORRECTION TO HIT VEEVA HARD: In a tweet, Andrew Left’s Citron Research said that, “[Veeva] price target $65. Competition has arrived as multiple is at peak and short interest at low. Same setup as [Nvidia] $NVDA at $280. A market correction will hit $VEEV harder than any other SaaS name. Buyout off the table until $40.” LEERINK SAYS BUY: In a research note this morning, Leerink’s Larsen initiated coverage of Veeva Systems with an Outperform rating and $120 price target, citing a significant number of tailwinds, earnings growth and potential. The analyst told investors that he likes how the company has leading market share in the “very attractive” Life Sciences space, and noted that the breadth of solutions in Veeva’s portfolio seems vast, high quality, and is growing. While Veeva is best known for its customer relationship management platform, Larsen likes how the company is expanding into the Electronic Data Capture market, as well as consumer packaged goods and other areas outside of Life Sciences. Further, Veeva has consistently posted “excellent” top-line growth and operating margins are “impressive” and continue to expand, he contended, adding that he likes how the management team is experienced and proven. PRICE ACTION: In afternoon trading, shares of Veeva Systems have dropped about 5% to $94.37.
AbbVie Phase 3 study shows significantly prolonged progression-free survival
AbbVie shared results from the ECOG-ACRIN Cancer Research Group, National Cancer Institute-sponsored, Phase 3 study evaluating Imbruvica plus rituximab versus the current National Comprehensive Cancer Network guidelines Category 1 treatment of fludarabine, cyclophosphamide and rituximab in previously untreated younger patients with chronic lymphocytic leukemia, CLL, and small lymphocytic lymphoma, SLL. This interim analysis showed that Imbruvica plus rituximab significantly prolonged progression-free survival, the primary endpoint of the study, compared to FCR, with a 65% reduction in risk of progression or death. Furthermore, Imbruvica plus rituximab significantly improved overall survival compared to FCR. The findings were presented today during the Late-Breaker abstract oral session at the 2018 American Society of Hematology, or ASH, Annual Meeting.
Aridis Pharmaceuticals granted Fast-Track, QIDP tags for cystic fibrosis med
Aridis Pharmaceuticals announced that the Cystic Fibrosis Foundation has more than doubled its research agreement for the clinical development of AR-501 from $2.9M to up to $7.5M. Aridis also announced that the U.S. Food and Drug Administration has granted both Fast-Track Designation and Qualified Infectious Disease Product Designation for AR-501. Additionally, the FDA cleared AR-501’s Investigational New Drug Application and the company intends to initiate the Phase 1/2a clinical trial next month.
Revance Therapeutics’ Botox rival succeeds in late-stage trial
A potential rival for Allergan Plc’s blockbuster Botox has passed a late-stage study, putting drug developer Revance Therapeutics Inc on course to file for U.S. marketing approval next year.
Revance shares climbed as much as 13 pct to $23.60 on Tuesday.
More than 95 percent of patients administered with Revance’s long-acting neuromodulator injection RT002 were found to have none or mild frown lines after four weeks, according to data from the third late-stage study.
The treatment, which requires two or less doses a year, was effective in maintaining reduced wrinkle severity in patients for a median duration of 24 weeks.
Revance Chief Executive Dan Browne said on a conference call the treatment, if approved, could receive a 24-week label.
Analysts have noted that patients are keen on long-lasting alternatives as opposed to treatments like Botox, which is labeled to be administered in 12-16 week or longer intervals.
Revance said the market for nerve activity regulating neuromodulators, which recorded total global sales of $4 billion in 2017, remains underpenetrated as currently available products do not address patient need for long-term results.
Revance’s treatment, which has a six-month median duration of effect, provides a meaningful advantage over competitive products such as Botox, analysts said.
The trial lessened some concerns investors had with respect to repeat dosing, SunTrust Robinson Humphrey analyst John Boris said in a note.
“Data was in-line with our expectations and supports premium pricing for RT002 when it’s launched in 2020,” said Boris, who expects the drug to bring in sales of $400 million in 2023.
Separately, Revance signed a license deal with China’s Fosun Pharma, covering exclusive rights to develop and commercialize RT002 in mainland China, Hong Kong and Macau.
According to the deal, Revance will receive an upfront payment of $30 million and is eligible to receive additional milestone payments of up to $230.5 million, besides tiered low-double-digit to high-teen royalty payments on future net sales.
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