Anchiano Therapeutics initiated with an Outperform at Oppenheimer. Oppenheimer analyst Leland Gershell initiated Anchiano Therapeutics with an Outperform rating and $16 price target. In a research note to investors, Gershell says Anchiano is committed to expanding treatment options for non-muscle invasive bladder cancer through its development of inodiftagene, a targeted biotherapeutic.
https://thefly.com/landingPageNews.php?id=2877025
Monday, March 11, 2019
Avedro initiated at JPMorgan
Avedro initiated with an Overweight at JPMorgan. JPMorgan analyst Robbie Marcus started Avedro with an Overweight rating and $16 price target. The company’s KXL platform for corneal cross-linking represents the only FDA-approved treatment proven to stop or slow the progression of keratoconus, Marcus tells investors in a research note. He sees a “clear pathway” to multiple years of double-digit sales growth for Avedro.
https://thefly.com/landingPageNews.php?id=2876981
https://thefly.com/landingPageNews.php?id=2876981
Hill Rom To Acquire Voalte, Inc.
Hill-Rom Holdings, Inc. (NYSE: HRC), today announced that it has entered into a definitive agreement to acquire Voalte, Inc., a pioneer and leader in real-time, mobile healthcare communications, for a cash consideration of $180 million and up to an additional $15 million in payments related to the achievement of certain commercial milestones. The acquisition of Voalte accelerates Hill-Rom’s leadership in care communications and advances the company’s digital and mobile communications platform and capabilities.
Voalte was founded in 2008 on the vision of simplifying communications and improving workflows and outcomes across the healthcare system. The company, based in Sarasota, Florida, currently serves more than 200 healthcare customers with more than 84,000 devices on its unique mobile platform. With annual revenue approaching $40 million, Voalte has demonstrated a consistent track record of driving durable, double-digit revenue growth and features a steady recurring revenue stream. Voalte’s comprehensive communications platform, which currently connects 220,000 caregivers across the healthcare enterprise, supporting voice, alarm and text communications, will be integrated with Hill-Rom’s care communications business. This combination will further strengthen Hill-Rom’s connected solutions, including smart hospital beds, vital signs monitors, the LINQ™ mobile application and its evolving digital offering, to deliver better care to patients and their care teams.
“Interoperability and connectivity have become critical elements in providing quality healthcare, reducing length of stay and driving efficiencies across the healthcare continuum,” said John P. Groetelaars, president and CEO of Hill-Rom. “This transaction strategically fits with our vision of advancing connected care to improve workflow and real-time actionable insights at the point of care, while driving accelerated growth and delivering an attractive margin profile. We look forward to welcoming and working closely with the talented Voalte team, and benefiting from Voalte’s technology, capabilities and substantial installed customer base to enhance outcomes for patients and their caregivers.”
“Our scalable enterprise communication platform is proving to be a critical tool in the digital transformation of healthcare systems, and we look forward to further developing our platform in alignment with Hill-Rom’s vision of advancing connected care,” said Trey Lauderdale, CEO of Voalte. “Bringing our companies together will allow us to offer customers a single, integrated solution – delivering actionable data from smart hospital beds, nurse call and patient monitoring technology right to a caregiver’s mobile device.”
Hill-Rom expects this transaction to close during its fiscal third quarter of 2019, subject to customary closing conditions. The transaction is expected to be modestly dilutive to adjusted earnings per diluted share in fiscal 2019, and increasingly accretive in fiscal 2020 and beyond. The company expects to absorb the dilutive impact in 2019, and does not expect the transaction to have a material impact on its fiscal 2019 adjusted earnings guidance. The company will provide additional information on its fiscal second quarter earnings conference call.
Lannett Enters Into Distribution Agreement For Generic Adderall
Lannett Company, Inc. (NYSE: LCI) today announced that it has entered into an agreement with Elite Pharmaceuticals and SunGen Pharma to be the exclusive U.S. distributor of a generic version of Adderall®, an immediate-release mixed salt of a single entity Amphetamine tablet product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate), with strengths of 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg and 30 mg tablets. Adderall® is a central nervous system (CNS) stimulant, indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.
“We expect to launch this generic version of Adderall® near term,” said Tim Crew, chief executive officer of Lannett. “We look forward to expanding this relationship and launching more products over time. We believe Elite and SunGen selected Lannett as the distributor of the product because of our team’s ability to launch products swiftly and execute launch plans well.”
Adderall® including generic versions have an estimated IQVIA market value of approximately $361 million for the 12 months ending January 2019, although actual generic market values are expected to be lower.
Under the agreement, Lannett will primarily provide sales, marketing and distribution support for the product, for which it will receive a share of the profits. Other financial terms were not disclosed.
EC OKs Roche combo in some lung cancers
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved and granted marketing authorisation for Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab), paclitaxel and carboplatin, for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC). In people with EGFR mutant or ALK-positive NSCLC, Tecentriq, in combination with Avastin, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies.
“Today’s announcement makes the combination of Tecentriq, Avastin and chemotherapy available to people in Europe with advanced, non-squamous non-small cell lung cancer.” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “This approval includes EGFR mutant or ALK-positive non-small cell lung cancer after failure of a targeted therapy marking a first for this subgroup of patients, in which there is a significant need for alternative treatment options.”
This approval is based on results from the Phase III IMpower150 study, which showed that Tecentriq in combination with Avastin and chemotherapy helped people live significantly longer, compared with Avastin and chemotherapy (median overall survival [OS]=19.8 versus 14.9 months; hazard ratio [HR]=0.76; 95% CI: 0.63-0.96; p=0.006) in the intention-to-treat (ITT) population.[1] The safety profile of the Tecentriq combination was consistent with that observed in previous studies.
FDA Action Alert: Regeneron, Celgene and Aerie
The next couple of weeks look to be busy for the U.S. Food and Drug Administration (FDA)with a string of target action dates scheduled. This week marks three scheduled approvals, two for extra indications for already-approved biologics, and the third for a combination treatment for glaucoma. Here’s a look.
Regeneron and Sanofi’s Dupixent for Atopic Dermatitis
Regeneron Pharmaceuticals and Sanofi have a target action date of Monday, March 11 for their supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) in adolescents ages 12 to 17 with moderate-to-severe atopic dermatitis that was inadequately controlled with topical therapies or where topical treatment wasn’t medically advisable. The indication is under Priority Review. There are no current FDA-approved systemic biologics for adolescents with this indication.
The drug is currently approved in the U.S. as a treatment for adults with moderate-to-severe atopic dermatitis that isn’t adequately controlled with topical therapies, as well as an add-on maintenance treatment for patients 12 years and older with moderate-to-severe asthma with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. Dupixent inhibits interleukin-4 and interleukin-13 signaling. This signaling is important in inflammation, particularly Type 2 inflammation, a systemic response that is important in moderate-to-severe atopic dermatitis.
Celgene’s Abraxane With Roche’s Tecentriq for Breast Cancer
Celgene has a target action date of Tuesday, March 12 for its sBLA filed by Roche for Abraxane (paclitaxel) in combination with Tecentriq (atezolizumab) for initial treatment of PD-L1-positive, metastatic triple-negative breast cancer (TNBC). Abraxane has been approved for various indications in metastatic breast cancer, advanced non-small cell lung cancer, and metastatic pancreatic cancer.
In October 2018, the companies announced positive results from the Phase III Impassion130 trial of the two drugs for first-line treatment of TNBC, showing a significant reduction in the risk of the disease worsening compared to chemotherapy alone.
“These important results in people with metastatic triple-negative breast cancer whose disease expresses the PD-L1 protein are highly encouraging and represent a significant step forward in the treatment of this challenging disease,” stated Sandra Horning, Roche’s chief medical officer and head of Global Product Development, in a statement at the time. “We have shared the Impassion130 results with global health authorities with the hope of bringing this Tecentriq combination to people with PD-L1-positive, metastatic triple-negative breast cancer as soon as possible.”
Aerie Pharmaceuticals’ Roclatan for Glaucoma
Aerie Pharmaceuticals, headquartered in Durham, NC, has a target action date of Thursday, March 14 for its New Drug Application (NDA) for Roclatan (netarsudil/latanoprost) for glaucoma and ocular hypertension (OHT). The eye drops are evaluated as a once-daily treatment. It combines netarsudil, which is the active ingredient in its approved product Rhopressa, with latanoprost, a prostaglandin analog (PGA) that is the most commonly prescribed drug for lowering IOP. If approved, it would be the first fixed-dose combination drug containing a PGA in the U.S.
The submission was based on data from two U.S. pivotal Phase III trials, MERCURY 1 and 2, which suggested the combination drug had the potential to provide greater IOP-lowering than the most common drugs for glaucoma.
Rhopressa was approved by the FDA in February 2018. At the company’s fourth-quarter reporton February 25, Vicente Anido, Jr., chairman and chief executive officer, stated, “We are delighted to have achieved the revenue guidance that we announced a full year ago, well before Rhopressa launched in the United States. With Rhopressa net sales having doubled from third-quarter to fourth-quarter 2018, and our significant progress in gaining market access, we are confident in the continued meaningful growth prospects for this very well-received product. Since we are just two weeks away from the Rocklatan PDUFA date, we will communicate full-year 2019 net revenue guidance after the FDA completes its review of Rocklatan.”
Natera, BGI Genomics announce $50M partnership
Natera and BGI Genomics announced a $50M partnership to commercialize Natera’s Signatera MRD test in China, and to develop reproductive health tests in select markets on BGI’s sequencing instruments using the DNBseq NGS technology platform. The Natera Signatera MRD and molecular monitoring test will be offered in China, first through specialty hospital networks and then more broadly, once Natera and BGI Genomics gain China’s regulatory approval for use of the Signatera test on the DNBseq technology platform. DNBseq is the market name of BGI’s proprietary sequencing technology, which supports its portfolio of next-generation sequencing platforms. BGI Genomics’ genetic testing leadership position in China, where it performs over 1 million cell-free DNA tests annually, will accelerate Natera’s entry into this large and growing oncology market.
https://thefly.com/landingPageNews.php?id=2876941
https://thefly.com/landingPageNews.php?id=2876941
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