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USFDA Approves First Generic of Daraprim

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USFDA Approves First Generic of Daraprim

Feb 28, 2020: The U.S. FDA  has approved an application for the first generic of Daraprim (pyrimethamine) tablets for the treatment of toxoplasmosis (an infection caused by the parasite Toxoplasma gondii) when used with a sulfonamide (a group of medicines used to treat bacterial infections).

Toxoplasmosis is an infection caused by a single-celled parasite named Toxoplasma gondii that can cause brain, eye or other organ damage if severe. A toxoplasma infection can occur, inter alia, by eating undercooked, contaminated meat or shellfish; drinking water contaminated with toxoplasma; or by accidental swallowing of the parasite through contact with toxoplasma-containing cat feces. It is considered the leading cause of death in the United States due to foodborne disease.

In pregnant women and people with weak immune systems, such as those with HIV or AIDS, those undergoing other forms of chemotherapy and those who have recently received an organ transplant, serious toxoplasmosis is more likely. However, even people with healthy immune systems can occasionally experience toxoplasmosis damage to the eyes.One focus area under the action plan is to improve the efficiency of the generic drug production, review and approval process, and to close loopholes that allow brand-name drug companies to avoid generic competition.

 As part of these important efforts, the FDA maintains a list of off-patent, off-exclusivity drug products without an approved generic in order to improve transparency and support the development and submission of applications for drugs with limited competition. Pyrimethamine is incorporated on this list. The FDA also prioritizes the review of the submissions for generic drugs for which there are fewer than three approved generic versions for the reference listed drug (RLD) and for which there are no blocking patents or exclusivities on the RLD.

In addition, certain “gaming” tactics have been used at times to delay generic competition. One example is when brand-name drug manufacturers attempt to prevent potential generic applicants from obtaining samples of the certain medicines necessary to support approval of a generic drug application. To increase clarity on this subject, the FDA posted a list describing all drugs for which a prospective generic applicant has received an inquiry concerning the limited distribution of the reference drug. Daraprim appears on this chart.

The most common side effects for pyrimethamine include hypersensitivity reactions (immune responses) that can irregularly be severe, such as Stevens-Johnson syndrome and toxic epidermal necrolysis (two forms of the same life-threatening disease that causes rash, skin peeling and sores on the mucous membranes), erythema multiforme (a skin disorder with bulls-eye-shaped lesions), anaphylaxis (a severe allergic reaction that may include difficulty breathing and shock) and hyperphenylalaninemia (elevated concentration of the amino acid phenylalanine in the blood), particularly when pyrimethamine is administered at the same time as a sulfonamide.

“Pyrimethamine should not be used in patients with known hypersensitivity to pyrimethamine or with documented megaloblastic anemia because of folate (a naturally-occurring B vitamin) deficiency. Women who takes pyrimethamine should not become pregnant. Patients should keep pyrimethamine out of the reach of children.”

A small “starting” dose for toxoplasmosis is recommended in patients with convulsive disorders in order to avoid the potential nervous system toxicity of pyrimethamine. Pyrimethamine should be used with caution in patients with impaired renal (kidney) or hepatic (liver) function or in patients with possible folate deficiency, such as individuals with malabsorption syndrome, alcoholism or pregnancy, and those receiving therapy, such as phenytoin (an anti-epileptic drug), affecting folate levels.

The sponsor of the approved generic version of the Daraprim Tablets is Cerovene Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, efficiency, and security of human and veterinary drugs, vaccines and other biological products for the human use, and medical devices. In addition,  agency is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-daraprim

USFDA accepts Roche’s Biologics License Application for fixed-dose subcutaneous combination of Perjeta and Herceptin for the treatment of HER2-positive breast cancer

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USFDA accepts Roche’s Biologics License Application for fixed-dose subcutaneous combination of Perjeta and Herceptin for the treatment of HER2-positive breast cancer

Feb 25, 2020: USFDA has accepts Roche’s Biologics License Application (BLA) for the fixed-dose combination (FDC) of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with hyaluronidase, administered by subcutaneous injection in combination with intravenous (IV) chemotherapy, for the treatment of eligible patients with HER2-positive breast cancer.

The BLA for the FDC is based on results from the Phase III study FeDeriCa, which demonstrated non-inferior levels of Perjeta in the blood (pharmacokinetics) and comparable efficacy and safety with Perjeta plus Herceptin and chemotherapy standard IV infusions. The FDC SC administration takes about eight minutes for the initial loading dose, and about five minutes for each subsequent maintenance dose.This is opposed to about 150 minutes for infusion using the normal IV formulations of a loading dose of Perjeta and Herceptin, and about 60-150 minutes for subsequent maintenance infusions of the two medicines.

The study of FeDeriCa reached its primary endpoint, with FDC SC administration showing non-inferior levels of Perjeta in the blood at a given dose interval (Ctrough) as opposed to Perjeta IV. A secondary endpoint of non-inferior Ctrough of Herceptin was also met, for the study to ensure that people were receiving sufficient dosing with Perjeta and Herceptin as compared to the established IV doses at the same treatment intervals. Additionally, rates of total pathological complete response (pCR), another secondary endpoint, were comparable between the treatment arms. The FDC’s safety profile in conjunction with chemotherapy was comparable with that of Perjeta’s IV administration plus Herceptin and chemotherapy and no new safety signals were found, including no significant difference in heart toxicity. Alopecia, diarrhoea, diarrhoea, and anaemia were the most common adverse events in both armrests.
In previous studies of other SC formulations, it has been shown that SC administration is strongly preferred by the majority of patients compared with IV administration of the same drug, with the most common reason being that administration in the clinic needed less time.

In the PHranceSCa report, Roche is currently investigating patient preference for FDC SC administration in humans with HER2-positive early breast cancer (eBC) compared to standard IV administration of Perjeta and Herceptin. Interim findings of this Phase II study will be discussed at a medical conference to come.
https://www.roche.com/media/releases/med-cor-2020-02-25.htm

Sanofi to create new industry-leading European company to provide active pharmaceutical ingredients

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Sanofi to create new industry-leading European company to provide active pharmaceutical ingredients

Feb 24, 2020: Sanofi plans to produce a major leading European company dedicated to the production and marketing to the third parties of active pharmaceutical ingredients (API), which are the important molecules responsible for the valuable effects used in the composition of any drug.

The project consists of creating a separate company which would combine Sanofi’s API commercial and development activities with six of its European API production sites : Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France).

With growing medicine shortages that significantly impact patient care, the new thing would contribute to supporting and securing API manufacturing as well as supply capacities for Europe and beyond. In Europe, the new API industry champion is expected in order to help in balancing the industry’s heavy reliance on API sourced from the Asian region.

With approximately € 1 billion in expected sales by 2022, the new company will rank as the world’s second-largest API firm. It is planned to hire 3,100 skilled staff and be headquartered in France. A proposed IPO on Euronext Paris would be evaluated according to market conditions, with a decision anticipated by 2022.

The new entity plans to increase its sales to third parties by operating independently and to extend its collaborations with other pharmaceutical companies in order to take advantage of new growth opportunities and have the ability to adapt deftly to customer needs. The new company would be exclusively positioned to benefit from its important competitive strengths, including a broad portfolio of both volume and niche products, high standards of quality, competitive pricing, state-of-the-art industrial capabilities and technologies across Europe (including France, Italy, Germany, Hungary, and the United Kingdom) as well as purchase an extensive commercial network covering more than 80 countries. 

Sanofi is fully dedicated to the new company’s success and intends to establish a long-term customer relationship with the new API supplier and to hold an alternative stake of about 30% in the new company. To provide the optimal conditions for success, Sanofi intends the new company to be debt-free in order to maximize its future investment capacities, and is committed to outstanding an important customer.
https://www.sanofi.com/en/media-room/press-releases/2020/2020-02-24-16-03-59

AstraZeneca divests global rights to Movantik (naloxegol)

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AstraZeneca divests global rights to Movantik (naloxegol)

Feb 25, 2020: AstraZeneca has decided to sublicense its global rights to Movantik (naloxegol), excluding Europe, Canada and Israel, to RedHill Biopharma (RedHill). Movantik is a peripherally acting mu-opioid receptor antagonist (PAMORA) and are indicated for the treatment of opioid-induced constipation (OIC).

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, said: “This divestment supports our strategy of realizing value from our portfolio of medicines that are mature or outside of our current scope to allow reinvestment in our main therapy areas. Movantik is an important established medicine and RedHill’s divestment will ensure its continued patient availability.”

According to the agreement, AstraZeneca will continue to manufacture and supply Movantik to RedHill during a transition period. In 2015, AstraZeneca entered into a co-commercialisation conformity with Daiichi Sankyo, Inc. for Movantik in the US, which will be transferred to RedHill.

Financial considerations: RedHill will make an direct payment of $52.5m to AstraZeneca on closing and a further non-contingent payment of $15m in 2021. Incomes arising from the upfront payment, balance by a charge for derecognition of the associated intangible asset, and the future payment will be reported in AstraZeneca’s financial statements in Other Operating Income & Expense. In 2019, Movantik generated sales of $96m in the US. The divestment is expected to complete in the first quarter of 2020, subject to expected closing conditions and regulatory clearances. After completion, the agreement will not impact the Company’s financial guidance for 2020.

Movantik: Movantik is a once-daily oral PAMORA approved by the US FDA for the treatment of OIC in the adult patients with chronic non-cancer pain. Movantik was licensed from the Nektar Therapeutics in 2009. In 2016, AstraZeneca divested the rights in Europe to ProStrakan Group (now KKI) and the rights in Canada and Israel to the Knight Therapeutics.
https://www.astrazeneca.com/media-centre/press-releases/2020/astrazeneca-divests-global-rights-to-movantik-25022020.html

Y-mAbs Announces Positive Pre-Biologics License Application Meeting with FDA for Omburtamab

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Y-mAbs Announces Positive Pre-Biologics License Application Meeting with FDA for Omburtamab

Feb. 26, 2020: Therapeutics announced that it has completed a positive Type B Pre-Biologics License Application (“Pre-BLA”) meeting with the U.S.FDA regarding a potential pathway for FDA approval of omburtamab for the treatment of patients with CNS/leptomeningeal metastases from neuroblastoma.

At the pre-BLA meeting, the Company reached placement with the FDA on an Accelerated Approval Pathway for omburtamab along with the rolling BLA submission. The Company expects to complete the rolling BLA in about 10 weeks.

“Under omburtamab’s breakthrough therapy designation, omburtamab qualifies for the rolling BLA submission, which allows for individual modules of the application to be submitted by Company and reviewed by the FDA on a rolling basis, rather than waiting for all sections of the BLA application to be completed before submission.”

“As formerly announced data readout from a single-center study (Study 03-133), at Memorial Sloan Kettering Cancer Center (“MSK”) where the 107 evaluable patients with the CNS/leptomeningeal metastases from neuroblastoma received up to two doses of the radiolabeled omburtamab and showed that the patients had a median survival of 50.8 months, with the final median survival not yet being reached. The Company plans to announce the complete clinical data package later this year. Additionally, the Company is planning for the submission of a Marketing Authorization Application in Europe in the fourth quarter this year.

Researchers at the MSK developed the omburtamab antibody, which is completely licensed by MSK to Y-mAbs. Consequently, MSK has institutional financial interests in the product and in Y-mAbs”.

About Y-mAbs: “Y-mAbs is a late-stage clinical biopharmaceutical company that focus on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. The Company has a broad and advanced product pipeline that includes two pivotal-stage product candidates—naxitamab and omburtamab—which target tumors that express GD2 and B7-H3, correspondingly.”
https://fda.einnews.com/pr_news/510656396/y-mabs-announces-positive-pre-bla-meeting-with-fda-for-omburtamab

NIH clinical trial of remdesivir to treat coronavirus disease 2019 (COVID-19) begins

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NIH clinical trial of remdesivir to treat coronavirus disease 2019 (COVID-19) begins

Feb 25, 2020: A randomized, controlled clinical trial to evaluate the safety and effectiveness of the investigational antiviral remdesivir in hospitalized adults diagnosed with coronavirus disease 2019 (COVID-19) has begun at University of Nebraska Medical Center (UNMC) in Omaha. The trial regulatory sponsor is the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH.

This is the first clinical trial in the United States in order to evaluate an experimental treatment for COVID-19, the respiratory disease first detected in December 2019 in Wuhan, Hubei Province, China.

The first participant in the trial is an American who was repatriated after being quarantined on the cruise ship Diamond Princess that docked in Yokohama, Japan and volunteered to participate in the study. The study can be adapted to evaluate additional investigative therapies and enroll participants at other sites in the United States and around the world.

The Food and Drug Administration (FDA) has not approved specific therapies for treating people with COVID-19, the disease caused by the newly emerging SARS-CoV-2 virus (formerly known as 2019-nCoV). Infection may cause mild to severe respiratory disease, and symptoms may include fever, cough, and breathing shortness. The World Health Organization (WHO) reported 77,262 confirmed cases of COVID-19 and 2,595 deaths in China as of 24 February, and 2,069 cases of COVID-19 and 23 deaths in 29 other countries.

According to the Centers for Disease Control and Prevention (CDC), there were 14 confirmed cases of COVID-19 reported in the United States, and an estimated 39 cases among people repatriated to the United States.Remdesivir, developed by Gilead Sciences Inc., is an investigational broad-spectrum antiviral treatment. It was previously tested in humans with Ebola virus disease and has shown promise in animal models for treating Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), which are caused by other coronaviruses.

Remdesivir clinical trials are underway in China, too. In line with the consultations convened by the WHO on the development of a therapeutic trial for patients with COVID-19, NIAID developed the current study taking into account those designs. Participants in the NIH-sponsored trial must have laboratory-confirmed SARS-CoV-2 infection and evidence of lung involvement, including rattling sounds when breathing (rales) requiring additional oxygen or abnormal X-rays in the chest, or mechanical ventilation disease. The study will not include individuals with reported infection who have mild, cold-like symptoms or no apparent symptoms.

Eligible patients will provide informed consent to participate in the trial, in accordance with standard clinical research protocols. On the first day of admission to the study, participants in the investigational therapy group will receive 200 milligrams (mg) of remdesivir intravenously. For the duration of the hospitalization, they will receive another 100 mg each day, for a total of up to 10 days. The placebo group will obtain a solution that resembles remdesivir, which contains only inactive ingredients, at an equal volume.
For more information, visit ClinicalTrials.gov and search identifier NCT04280705. https://www.nih.gov/news-events/news-releases/nih-clinical-trial-remdesivir-treat-covid-19-begins

Novartis announces FDA and EMA filing acceptance of ofatumumab (OMB157), a novel B-cell therapy for patients with relapsing forms of multiple sclerosis (RMS)

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Novartis announces FDA and EMA filing acceptance of ofatumumab (OMB157), a novel B-cell therapy for patients with relapsing forms of multiple sclerosis (RMS)

Feb 24, 2020: Novartis announced that both the USFDA and EMA have accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab (OMB157) for the treatment of relapsing forms of multiple sclerosis (RMS) in the adults.

Ofatumumab is a novel B-cell therapy that delivers sustained efficiency with a favorable safety profile.

If approved, ofatumumab has the prospective to become a first-choice treatment for the broad RMS population and the first B-cell therapy that can be easy to start and manage in a monthly subcutaneous injection that can be self-administered at home using an autoinjector pen.

The regulatory applications are based on the positive data from Phase III ASCLEPIOS I and II studies, which investigated the effectiveness and safety of monthly subcutaneous ofatumumab 20mg against once daily oral Aubagio®* (teriflunomide) 14mg in adults with RMS. In both head-to-head studies, ofatumumab demonstrated dominance over Aubagio® in patients with RMS

All research reached the primary endpoints where ofatumumab demonstrated a highly significant and clinically meaningful decrease in the number of reported relapses, measured as the annualized relapse rate (ARR). Key secondary delay time endpoints for confirmed progression of disability (CDP) were also met. Data presented at the 35th Congress of the European Committee for Multiple Sclerosis Treatment and Research (ECTRIMS) showed that ofatumumab reduced ARR by 50.5% (0.11 vs. 0.22) and 58.5% (0.10 vs. 0.25) (p<0.001 in both studies) respectively in ASCLEPIOS I and II compared with Aubagio ®. Showed highly important suppression of both Gd+ T1 lesions and new or enlarging T2 lesions, demonstrating a profound abrogation of new inflammatory activity. Showed a relative risk reduction of 34.4%  in three-month CDP and 32.5%  in six-month CDP in pre-specified pooled analyses

In general ofatumumab, a potent, fully-human antibody targeting CD20 positive B-cells, delivered efficacy with a favorable safety profile. The safety profile of the ofatumumab as seen in the ASCLEPIOS studies is in line with the observations from Phase II results.

Additionally, Novartis has completed the APLIOS study, an open-label Phase II study which is to determine the bioequivalence of subcutaneous administration of ofatumumab via a pre-filled syringe – as used in ASCLEPIOS I and II – and an autoinjector pen in patients with RMS. The positive results of the study will be presented at the Americas Committee for Treatment and Research in the Multiple Sclerosis (ACTRIMS) Forum in Florida, US. These results show that ofatumumab offers a highly efficient B-cell therapy that can be self-administered at home using a patient-friendly autoinjector pen.

Regulatory approval for the ofatumumab in US is expected in June 2020 and in Europe by Q2 2021. Novartis is committed to bringing ofatumumab to the patients worldwide and additional regulatory filings are currently underway.
https://www.novartis.com/news/media-releases/novartis-announces-fda-and-ema-filing-acceptance-ofatumumab-novel-b-cell-therapy-patients-relapsing-forms-multiple-sclerosis-rms

Novartis receives EC Approval for Beovu®(brolucizumab), a next-generation anti-VEGF treatment for wet AMD, a leading cause of blindness worldwide

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Novartis receives EC Approval for Beovu®(brolucizumab), a next-generation anti-VEGF treatment for wet AMD, a leading cause of blindness worldwide

Feb 17, 2020: Novartis announced the European Commission has approved Beovu® (brolucizumab) injection for the treatment of wet age-related macular degeneration (AMD). Beovu is the first EC-approved anti-VEGF treatment to demonstrate superior resolution of the retinal fluid (IRF/SRF), a key marker of the disease activity, versus aflibercept (secondary endpoints).

“Beovu also offers the ability to start qualified wet AMD patients on a three-month dosing interval immediately after the loading phase. This decision of EC is applicable to all 27 European Union member states as well as the UK, Iceland, Norway and Liechtenstein.

 “Drying the retina is one of the main goals in the treatment of wet AMD with anti-VEGF therapy.”Wet AMD is a chronic, degenerative eye disease caused by excess VEGF, a protein that encourages the development of enlarged blood vessels below the macula, the region of
the retina responsible for sharp, central vision. The condition is a leading cause of significant
loss of vision and blindness in individuals over 65 years of age, affecting more than 20 million people worldwide. Initial symptoms of wet AMD include blurry or wavy vision. As the disease progresses, patients lose central vision, making it complicated to see objects directly in front of them.

The EC approval was based on the findings from the Phase III HAWK and HARRIER clinical trials, in which Beovu met the primary endpoint, demonstrating gains in the best-corrected visual acuity (BCVA) that were non-inferior to aflibercept at year one (week 48). Vision gains at year one and was maintained at year two.

In HAWK and HARRIER, over half of the patients were maintained on the three-month dosing interval (56% in HAWK and 51% in HARRIER) at year one. The leftover patients in the study were treated on a two-month dosing interval.

Novartis received approval from the U.S. FDA in October 2019 for Beovu for the treatment of wet AMD. Beovu received Swissmedic approval in Switzerland and Australian TGA approval in January 2020  for the treatment of wet AMD. Novartis is committed to bringing Beovu to the patients worldwide, and other regulatory filings are at present underway in Canada, Japan and Brazil.

About Beovu (brolucizumab): Beovu (brolucizumab, also known as RTH258) is the most
scientifically advanced single chain humanized fragment of an antibody (scFv). Due to their small size, improved tissue penetration, rapid clearance from systemic circulation and drug delivery characteristics, singlechain antibody fragments are highly sought after in drug development.

About wet age-related macular degeneration
Wet AMD is the leading cause of severe vision loss and legal blindness in the people above 65 years age in North America, Europe, Australia and Asia, impacting an approximate 20 million people worldwide. Wet AMD occurs when abnormal blood vessels from the bottom of the macula, the area of the retina responsible for the sharp, central vision. These blood vessels are fragile and leak fluid, disrupting the typical retinal architecture and eventually causing damage to the macula”.

https://www.novartis.com/news/media-releases/novartis-receives-ec-approval-beovu-next-generation-anti-vegf-treatment-wet-amd-leading-cause-blindness-worldwide

US FDA Grants Orphan Drug Designation for Retrotope’s RT001 in the Treatment of Progressive SupraNuclear Palsy (PSP)

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US FDA Grants Orphan Drug Designation for Retrotope’s RT001 in the Treatment of Progressive SupraNuclear Palsy (PSP)

Feb. 18, 2020: Retrotope announced that the U.S.FDA Office of Orphan Products Development granted orphan drug designation for its chemically-modified polyunsaturated fatty acid drug (RT001) for the treatment of Progressive SupraNuclear Palsy (PSP).

Physicians collaborating with the Retrotope have earlier received approval from the FDA’s Division of Neurology Products to test RT001 in Expanded Access trials of three patients having PSP, an orphan neurodegenerative disorder that causes progressive impairment of the balance and walking; impaired eye movement, abnormal muscle rigidity; dysarthria; and dysphagia and eventual death.

PSP is a serious neurodegenerative disease that intensely affects the quality and length of life in adults. Patients are usually disabled within 3-5 years of disease onset. It affects an approximate 17,500 adults in the US. The exact cause of PSP is not known, but it is a form of tauopathy, in which abnormal phosphorylation and accumulation of the protein tau in mid brain leads to destruction of the vital protein filaments in nerve cells, causing their death. Most cases appear to be irregular as an acquired tauopathy and there is no approved drug therapy. A regionally specific increase in the lipid peroxidation has been observed in PSP and mitochondrial structures and functions are compromised and leads to profound oxidation damage. 

RT001 is a chemically stabilized fatty acid that, via a novel mechanism, confers resistance to lipid peroxidation in mitochondrial and cellular membranes. In PSP patient mesenchymal stem cells, RT001 has been shown to decrease lipid peroxidation levels and restore mitochondrial structure and function to damaged cells. As RT001 is distributed across human tissues as an essential fat, it is expected to decrease the amount of lipid peroxidation, restore normal mitochondrial function and prevent mitochondrial cell death.https://fda.einnews.com/pr_news/510001029/us-fda-grants-orphan-drug-designation-for-retrotope-s-rt001-in-the-treatment-of-progressive-supranuclear-palsy-psp

MediciNova Receives Notice of Allowance from the Japan Patent Office for New Patent Covering MN-001 and MN-002 for the Treatment of Advanced NASH in Japan

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MediciNova Receives Notice of Allowance from the Japan Patent Office for New Patent Covering MN-001 and MN-002 for the Treatment of Advanced NASH in Japan

Feb. 17, 2020: MediciNova announced that it has received a Notice of Allowance from the Japan Patent Office for a pending patent application which covers MN-001 (tipelukast) and MN-002 (a chief metabolite of MN-001) for the treatment of advanced non-alcoholic steatohepatitis (NASH). 

The patent maturing from this approved patent application is scheduled to expire no earlier than May 2035 upon issuance. The permissible statements cover MN-001 and MN-002 for use in treating an advanced NASH patient.

Advanced patients with hepatic fibrosis, spider angiomata, ascites, splenomegaly, hard liver border, palmar erythema, asterixis, portal hypertension, hepatic scarring, cirrhosis, or hepatocellular carcinoma (HCC) are also covered by the permitted claims. Furthermore, the permissible claims cover MN001 and MN 002 for use in hepatic fibrosis reduction and for use in patients with reduced hepatic scarring. The allowed claims include oral administration, including tablets and capsules, as well as liquid dosage forms. MN 001 (tipelukast) is a novel, orally bioavailable small molecule compound thought to exert its effects in preclinical models through several mechanisms to achieve its anti-inflammatory and anti fibrotic action, including leukotriene (LT) receptor antagonism, phosphodiesterase inhibition (PDE) (mainly 3 and 4) and 5-lipoxygenase inhibition (5-LO).

 The 5 LO / LT pathway was postulated as a pathogenic factor in the development of fibrosis, and the inhibitory effect of MN 001 on 5 LO and the 5 LO / LT pathway is considered a novel approach to fibrosis treatment. MN-001 has been shown to down-regulate the fibrosis-promoting gene expression including LOXL2, Collagen Type 1 and TIMP-1.
https://investors.medicinova.com/news-releases/news-release-details/medicinova-receives-notice-allowance-new-patent-covering-mn-17

Arctoris announces a formal partnership with Molecule to tackle the innovation crisis in the drug discovery and development

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Arctoris announces a formal partnership with Molecule to tackle the innovation crisis in the drug discovery and development

Feb 10, 2020: Arctoris Ltd has announced a formal partnership with Molecule to address the ongoing crisis of innovation faced by drug discovery and development across industry and  academia alike. “Arctoris helps researchers and biotechnology entrepreneurs to design and conduct advanced cellbased, molecular biology, and biochemical assays remotely through its fully automated drug discovery platform. Together with Molecule’s collaborative IP ownership network, which enables drug development stakeholders to collaborate and share ownership of the IP they work to develop, Arctoris and Molecule are positioned to take crucial steps to make drug discovery and production quicker, cheaper, less risk-prone and more competitive at all levels.

“Drug discovery researchers worldwide face enormous challenges posed by a wide-ranging lack of reproducibility and the limited ease of use of standardised, structured, high-quality data. By partnering with Molecule, we plan to make drug discovery and development more democratic, collaborative, and well-organized in the interest of bringing higher-quality therapeutics to the patients faster through the combination of robotics, AI and a distributed research platform,” said Martin-Immanuel Bittner, MD DPhil, Co-Founder and CEO of Arctoris.
Arctoris has planned and built a fully automated research facility based in Oxford (UK), where robotics perform a range of the most recurrent drug discovery assays for the researchers globally. The company offers the complete system in order to generate, analyse and visualize research data in a secure cloud environment, leveraging the benefits of the robotic experimentation, and providing full transparency, precision, and consistency in the preclinical R&D. Using the Arctoris platform, researchers worldwide can enjoy accelerated progress in their research, making discoveries faster, cheaper and more economically, while being liberated from manual work.
Jointly, Arctoris and Molecule will combine their technologies to create a modular pipeline for the distributed therapeutics development in the durability space and adjacent fields – a pipeline in which they will engage universities, patient advocacy groups, pharmaceutical and biotechnological companies, as well as investors”.
https://www.pharmiweb.com/press-release/2020-02-17/arctoris-announces-partnership-with-molecule-to-tackle-the-innovation-crisis-in-drug-discovery-and-development

Lupin received approval from U.S. FDA and launches Moxifloxacin Ophthalmic Solution USP 0.5%

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Lupin received approval from U.S. FDA and launches Moxifloxacin Ophthalmic Solution USP 0.5%

Feb 14, 2020: Pharma major Lupin Limited announced the launch of Moxifloxacin Ophthalmic Solution USP, 0.5%, having received an approval from the U.S. FDA earlier. The product would be manufactured at the Lupin’s Pithampur (Unit-II) facility in India. Moxifloxacin Ophthalmic Solution USP, 0.5% is the AT2-rated generic equivalent of the Moxeza® of Novartis.

It is indicated for the treatment of bacterial conjunctivitis which is caused by susceptible strains of certain organisms. Moxifloxacin Ophthalmic Solution USP, 0.5% (RLD: Moxeza®) had an annual sales of about USD 10 million in the U.S. (IQVIA MAT December 2019).

Lupin has 15 production facilities, seven research centres, more than 20,000 global employees, and has been widely known as a ‘ great place to work ‘ in the biotechnology & pharmaceuticals industry.
http://www.lupinpharmaceuticals.com/lupin-launches-moxifloxacin-ophthalmic-solution-usp-0-5.htm

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