Friday, September 28, 2018
Taro Pharmaceutical terminates license agreement with NovaBiotics
Taro Pharmaceutical Industries announced that it has terminated the license agreement with NovaBiotics for the onychomycosis drug, Novexatin. As previously disclosed in May 2018, the Novexatin clinical study did not meet the main goal of a Phase IIb study under current guidelines of the FDA and did not show superiority over the placebo. Upon further analysis and evaluation, the Company has decided to terminate its agreement with NovaBiotics.
https://thefly.com/landingPageNews.php?id=2797335
Insmed wins FDA approval for lung disease treatment
Insmed’s (NASDAQ:INSM) Arikayce — amikacin liposome inhalation suspension — has won FDA approval for treating a lung disease caused by mycobacterium avium complex, in a limited population of patients not responding to conventional treatment.
The advisory panel in August failed to broadly back the drug for that application, but it did get an OK as part of a combination for patients with few or no treatment options.
The label has a boxed warning about an increased risk of respiratory conditions.
Bloomberg estimates the drug can bring in 2019 sales of $82.8M, rising to more than $500M by 2022.
Shares were halted at 4:35 p.m. for the pending news and haven’t gotten a reopening time yet.
Updated 6:04 p.m.: Insmed issues a press release about the approval and sets a conference call at 6:15 p.m. (in a few minutes) to discuss it. Insmed says it’s collaborating with the FDA on the design of an additional clinical study to support full approval.
Novavax Nanoparticle Flu Vaccine for Older Adults Begins Phase 2 Trial
A new phase 2 trial is underway for an investigative nanoparticle seasonal influenza vaccine in older adults. Novavax, creators of the NanoFlu, will undergo a randomized, observer-blind trial prior to a meeting with the US Food and Drug Administration (FDA) to discuss appropriate phase 3 trial design accommodated by accelerated approval designation.
In the new clinical trial, investigators will assess the efficacy, safety, and tolerability of NanoFlu doses and formulationsboth adjuvanted and unadjuvantedin comparison to a pair of US marketed vaccines. Approximately 1375 healthy older adults across the country will be enrolled, with Novavaxs intent to select a dose and formulation of the vaccine that can be brought forward into its phase 3 immunogenicity trial.
NanoFlu trivalent formulation first reported topline phase 1 and 2 clinical trial results in older adults in Feburary of this year. When compared to Fluzone HD, the investigative vaccine demonstrated acceptable safety and a short-term reactogenicity. Investigators also reported patient hemagglutination inhibition (HAI) immune responses were 28% to 64% greater in those treated with NanoFlu versus those treated with homologous and 4 generations of drifted wild-type A(H3N2) influenza strain. The vaccine also reported higher HAI responses than the homologous A(H1N1) strain, and comparable responses against the homologous B/Brisbane strain.
Influenza is a particular concern among adults aged 65 years or older, advised the US Centers for Disease Control and Prevention (CDC), due to the populations increased risk of infection and comorbidities. Vaccination has also been pointed to the greatest resolvea 2017 study run by the CDC showed that rates of death, intensive care unit admissions and length of stay, and overall hospitalization duration were most significantly improved by vaccine in people aged 65 years and older.
As a recombinant hemagglutinin (HA) protein nanoparticle vaccine, the NanoFlu contains Novavaxs Matrix-M adjuvant. The adjuvant stimulates entry of antigen-presenting cells into the injection site and enhances antigen presentation in local lymph nodes, result in potent and well-tolerated effects in older adult populations.
Gregory Glenn, MD, president of Research and Development at Novavax, suggested the characteristics and makeup of the investigative vaccine make it a sorely missing option in the influenza market.
The dual problems of antigenic drift and antigenic changes resulting from egg-based vaccine production have, in recent years, resulted in generally poor influenza vaccine effectiveness with potentially severe medical consequences, particularly in older adults, Glenn said in a statement. A substantially improved seasonal influenza vaccine is a widely recognized, high-priority unmet medical need.
Stanley C. Erck, president and chief executive officer of Novavax, is anticipating topline results from the phase 2 trial in the Q1 of 2019. He called the initiation of this phase an important milestone for the company.
Kalytera Sees Progress with Cannabinoid-Based Pain Treatment
Kalytera Therapeutics, Inc. (TSX VENTURE: KALY and OTCQB: KALTF) (the “Company” or “Kalytera”) today announced a major step forward in its program to develop the first cannabinoid-derived pain treatment targeting activation of alpha3 glycine receptors.
When activated, the alpha3 glycine receptor strongly blocks pain signals from being sent to the brain. Kalytera, and its research partner, Beetlebung Pharma Ltd. (BPL), have carried out a medicinal chemistry program to identify a novel analogue of cannabidiol (CBD) that will block such pain signals via the activation of the alpha3 glycine receptor channel in the spinal cord. To date, no company has introduced into the market an agent specifically targeting this receptor.
Through a series of manipulations of the structure of CBD, a new compound has been invented. This new compound is 40-fold more potent than desoxy-CBD, which is the prototypic alpha3 glycine receptor agonist. The new compound activates only the alpha3 glycine receptor and has no effect on a closely related protein, known as the alpha1 glycine receptor, which may produce unwanted symptoms of muscle weakness.
Based on these findings, Kalytera believes that this novel molecule constitutes the first completelyselective alpha3 glycine receptor agonist that can potently activate this critical analgesic pathway without producing complications via the alpha1 glycine receptor pathway.
The high potency of the compound and its total selectivity justify its advancement to human clinical testing as a potential substitute for opioids in the treatment of severe pain. Kalytera is now preparing to evaluate the compound in various animal models in order to select the optimal pain setting in which to conduct human clinical testing.
Patents for this compound have been filed in the U.S. and other jurisdictions, and Kalytera has obtained an exclusive, worldwide license for this compound from BPL. BPL is an Israeli-based pharmaceutical discovery company focused on cannabinoid-based therapeutics for the treatment of human disease.
The objective of our program is to develop a potent, non-psychotropic, oral analgesic for intractable pain that will be safe and well tolerated. The cannabinoid compound that has been invented has the potential to achieve these goals, and become a next generation pain medication, stated Robert Farrell, President and CEO of Kalytera. “This novel compound may provide effective pain reduction, without the risks of addiction or respiratory suppression that exist with opioid analgesics. We have also found a way to make this compound water soluble, which will allow for treatment of acute pain in in-patient settings, such as childbirth, short surgical procedures, and post-operative pain care.
FDA Approves Genentech Xolair Prefilled Syringe Formulation
– Xolair, the only biologic approved for both allergic asthma and chronic idiopathic urticaria indications, is now also approved in a prefilled syringe (PFS) formulation –
– More than 330,000 patients have been treated with Xolair in the last 15 years –
– The 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes are expected to be available by the end of 2018 –
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved 75 mg/0.5 mL and 150 mg/1 mL single-dose prefilled syringes (PFS) for Xolair® (omalizumab) as an additional formulation for both allergic asthma and chronic idiopathic urticaria (CIU) indications. The new Xolair PFS formulation is expected to be available by the end of this year for the first time in the U.S. Xolair is currently available in a 150 mg single-dose vial with lyophilized, sterile powder for reconstitution.
“Xolair has long been an important treatment option for people with allergic asthma and CIU,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “The prefilled syringe formulation reflects our continued commitment to provide healthcare professionals with choices to best support each patient’s unique needs.”
The Xolair PFS eliminates the need for healthcare providers to procure Sterile Water for Injection (SWFI) and reconstitute Xolair before administering the medicine.
Xolair is approved for the treatment of moderate to severe persistent allergic asthma in people six years of age or older whose asthma symptoms are not controlled by inhaled corticosteroids, and for CIU in people 12 years of age and older who continue to have hives that are not controlled by H1 antihistamines. Over 330,000 people in the U.S. have been treated with Xolair since its initial approval for people 12 years and older with allergic asthma in 2003.
Insmed shares halted pending news
Nasdaq has suspended trading in Insmed (NASDAQ:INSM) pending the release of news, a near certainty that it is related to the pending FDA approval for ALIS for nontuberculous mycobacteria (NTM) lung disease.
FDA OKs Regeneron and Sanofi’s Libtayo for type of skin cancer
The FDA approves Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi’s (NYSE:SNY) PD-1 inhibitor Libtayo (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma, the second most common type of skin cancer.
The U.S. list price will be $9,100 per three-week cycle.
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