Lannett said that its distribution agreement with Jerome Stevens Pharmaceuticals, or JSP, which expires on March 23, 2019, will not be renewed. “The Steinlauf family advised us this past Friday evening that they will not renew our agreement to distribute three JSP products: Butalbital, Aspirin, Caffeine with Codeine Phosphate Capsules USP, Digoxin Tablets USP and Levothyroxine Sodium Tablets USP, upon its expiration in March 2019,” said Tim Crew, CEO of Lannett. “The family has assured us of a continuous supply of the products through March of next year. These products remain valuable assets for us and are expected to significantly contribute to our financial performance in fiscal 2019.”
Monday, August 20, 2018
Ventas to acquire premier seniors housing in Manhattan from Brookdale
Ventas (VTR) announced that it has signed a definitive agreement to acquire a premier seniors housing community located in the appealing Battery Park City neighborhood of downtown Manhattan for approximately $194M from Brookdale Senior Living (BKD).
Aquestive Therapeutics initiated at JMP Securities
Aquestive Therapeutics initiated with an Outperform at JMP Securities. JMP Securities analyst Jason Butler initiated Aquestive Therapeutics with an Outperform rating and $29 price target, stating that the benefits of its core oral-film-based delivery technology has been validated through multiple successful partnerships and the company is now leveraging it on an internal pipeline of drug candidates. He believes FDA approvals for wholly owned candidates including Libervant and Sympazan are likely over the next 12-18 months, Butler tells investors.
Amneal Pharmaceuticals announces license agreement with Jerome Stevens
Amneal Pharmaceuticals announced a 10-year license and supply agreement for Levothyroxine sodium tablets with Jerome Stevens Pharmaceuticals, a New York-based pharmaceutical manufacturer of prescription tablet and capsule formulations. The agreement is effective March 22, 2019. The agreement includes an upfront milestone payment upon commercialization and a profit share on future sales of Levothyroxine. Further terms of the agreement were not disclosed.
Zai Lab announces completion of study for ovarian cancer patients
Zai Lab announced the early completion of an open-label study to evaluate the pharmacokinetic, or PK, profile of ZL-2306 made in China in Chinese ovarian cancer patients. The study demonstrated comparable PK profile of Chinese patients who were administered ZL-2306 to the PK profile of patients evaluated in Tesaro’s clinical trials using product manufactured outside of China. These results are important in supporting the regulatory review of ZL-2306, a potent and highly selective PARP1/2 inhibitor, in ovarian cancer patients in mainland China. The open-label PK Study enrolled 36 subjects with dose levels ranging from 100mg, 200mg and 300mg, and assessed the PK profile of ZL-2306 made in China. The objective was to evaluate ZL-2306’s PK profile and tolerability in Chinese patients, and to compare the key PK parameters with global data. The results showed that the drug exposure increased proportionally from 100mg to 300mg, with no unexpected safety issues noted. All key PK parameters were comparable to those in global studies. The population PK data and analysis showed no ethnicity differences between Chinese and non-Chinese patients.
Sunday, August 19, 2018
Sensyne Health’s IPO: AI in Healthcare is Hot
Sensyne Health, a London-based healthcare artificial intelligence (AI) company founded by biotech entrepreneur Paul Drayson, recently launched an initial public offering (IPO) on the London AIM market. Drayson’s plan is to raise $78 million. It’s just one of many companies that are exploiting advances in computing, data science and AI to help identify and develop potential new drugs.
Drayson was formerly the UK’s Minister of Science in the Department for Business, Innovation and Skills until May 2010, and before that, Minister of State for Strategic Defence Acquisition Reform at the Ministry of Defence. Drayson co-founded vaccine maker PowderJect Pharmaceuticals in 1993 and sold it in 2003 to Chiron for 524 million pounds.
Sensyne uses AI to analyze patient data from the UK’s National Health Service, analyzing for “clinical insight that can be exploited commercially by the pharmaceutical industry,” notes the Financial Times. “The company, which changed its name from Drayson Health last month, has an unusual business model based on exclusive partnerships with a small number of NHS trusts.”
Those deals have included Oxford University Hospitals, South Warwickshire and Chelsea & Westminster trusts.
Drayson notes that there’s plenty of competition. “Google DeepMind is the main competitor and benchmark for what we are doing with clinical data,” he told the Financial Times. “Flatiron is doing something similar in the U.S., particularly in oncology.”
In February, Flatiron Health was acquired by Swiss-based Roche for $1.9 billion. Roche already had a 12.6 percent stake in Flatiron, but the deal brought the AI company completely under Roche’s umbrella. Flatiron Health developed its Health OncologyCloud platform, which includes an electronic medical record system for oncology, advanced analytics, patient portal and integrated billing management. It also aggregates data to be used by researchers. In May, Flatiron extended a three-year collaboration deal with Bristol-Myers Squibb.
On August 16, The Buck Institute for Research on Aging, Insilico Medicine, an AI company with offices and resources in the U.S., Belgium, Russia, the UK, Taiwan and Korea, and Juvenescence,a human longevity company, founded Napa Therapeutics to develop drugs against a novel aging-related target.
Napa Therapeutics is built on research in NAD metabolism conducted by Eric Verdin, president and chief executive officer of the Buck Institute. His laboratory will collaborate with Napa, using Insilico’s drug development platform to accelerate compound discovery. “This is a unique opportunity to use cutting-edge AI to accelerate drug discovery,” Verdin said in a statement. “The Buck is excited to join forces with Insilico and Juvenescence as we work to eliminate the threat of age-related disease for this and future generations.”
And there are plenty of other examples.
In April, London-based BenevolentAI, which applies AI to developing new medicines, brought in $115 million in new investments. Since its founding in 2013, it’s raised more than $200 million. The company has 20 drug programs in its pipeline with a focus on rare diseases, including motor neuron disease, Parkinson’s disease, glioblastoma and sarcopenia.
In September 2017, startup guru Vivek Ramaswamy opened yet another company, this one called Datavant, which will utilize artificial intelligence to improve clinical trials. It’s led by Travis May, co-founder and chief executive officer of LiveRamp, which offers data analysis across their ecosystem. The focus of Datavant is on collecting data across various silos, including pharma companies, universities, healthcare consortia, CROs, research groups, hospitals, patient registries and others. At its inception, it had pulled together data from 85 different datasets made up of over 20 million patient visits.
In July 2017, GlaxoSmithKline inked a $43 million deal with AI company Excientia to stimulate drug development. GSK indicated it would use AI to discover novel and select molecules for up to 10 disease-related targets across multiple therapeutic areas.
And in the same month, Mayo Clinic and nference launched a startup called Qrativ that uses AI and clinical expertise to develop drugs.
Although Sensyne would appear to be working in an area filled with other companies doing similar things, Drayson told the Financial Times that Sensyne’s distinguishing feature is that “the development of our AI algorithms has been led by clinicians [at Oxford University] rather than by computer scientists.” He went on to say that, “Our focus is on the chronic diseases that place the greatest burden on the NHS. That means lung disease, cardiovascular disease, cancer and immunological diseases like cancer.”
FDA Action Alert: Mallinckrodt, Kala Pharma, Merck, Eisai and More
It’s a busy week on the U.S. Food and Drug Administration (FDA)’s calendar, although the agency got ahead of itself and approved three of the applications early. Here’s a look.
Agios Pharmaceuticals had a Prescription Drug User Fee Act (PDUFA) action date of Tuesday, August 21, for its ivosidenib (AG-120) for patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation. However, the FDA approved this application early, on July 20. The FDA granted the drug Priority Review. The drug is a first-in-class, oral, targeted inhibitor of mutant IDH1. In a related note, Abbott submitted a Premarket Approval (PMA) application for an IDH1 assay on the Abbott 2000 RealTime System, an automated sample preparation and batch analyzer system. Agios and Abbott signed a deal in 2014 where Abbott was responsible for developing and commercializing a RealTime PCR assay for IDH1 mutations in bone marrow and blood, which will act as a companion diagnostic for ivosidenib.
Mallinckrodt Pharmaceuticals has a target action date of Wednesday, August 22 for stannsoporfin for the treatment of neonates at risk for developing severe jaundice (hyperbilirubinemia). The drug received Fast Track status. The drug is a heme oxygenase inhibitor that has the potential to cut the production of bilirubin in infants at risk for jaundice.
Kala Pharmaceuticals has a target action date of Friday, August 24 for Inveltys (KPI-121 1%), a topical twice-a-day treatment for inflammation and pain in patients after ocular surgery. If approved, it will be the first twice-daily ocular corticosteroid for the treatment of postoperative ocular inflammation. All the others are approved four times a day. The compound uses the company’s proprietary Mucus Penetrating Particle (MPP) technology.
Also Friday, August 24, Merck & Co. and Eisai were expecting a response to their supplemental New Drug Application (sNDA) for lenvatinib for the potential first-line treatment of unresectable hepatocellular carcinoma (HCC). This date was an extension from the original date of May 24, as the FDA wanted more time to review the application. They approved the drug a week early, on Friday, August 16. The drug, marketed as Lenvima, is approved in the U.S. for locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. It has also been approved in the U.S. in combination with everolimus in patients with advanced renal cell carcinoma after one prior anti-angiogenic therapy.
Friday, August 24 is a busy day for the agency. Regeneron Pharmaceuticals is waiting on a supplemental Biologics License Applications (sBLA) for use of Praluent (alirocumab) for use with apheresis. Praluent is a PCSK9 inhibitor for high cholesterol. Apheresis is a nonsurgical procedure that removes low-density lipoprotein (LDL) cholesterol from a patient’s blood.
Shionogi & Co had a PDUFA date of Sunday, August 26 for its NDA for lusutrombopag for treatment of thrombocytopenia in patients with chronic liver disease at increased risk for bleeding associated with invasive procedures. The FDA approved the drug on August 1. The submission was based on two Phase III clinical trials that showed the drug met the pre-specified primary and all key secondary endpoints. The drug also had Priority Review status. Lusutrombopag is an oral, small molecule agonist of the human thrombopoietin receptor. It was approved in 2015 in Japan for the same indication.
Shire also has a PDUFA date of Sunday, August 26. In Shire’s case, it’s for lanadelumab’s BLA for angioedema attacks in patients 12 years and older with the rare, genetic disorder, hereditary angioedema. The FDA also granted the drug Priority Review. Lanadelumab is a fully human monoclonal antibody that specifically binds and inhibits plasma kallikrein.
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