Monday, December 17, 2018
Amgen submits BLA for ABP 710 to FDA
Amgen announced the submission of a Biologics License Application to the U.S.FDA for ABP 710, a biosimilar candidate to REMICADE.
https://thefly.com/landingPageNews.php?id=2837929
Medtronic announces FDA approval of InterStim smart programmer
Medtronic (MDT) announced U.S. Food and Drug Administration approval of the InterStim smart programmer for use with the InterStim system, which provides sacral neuromodulation therapy for the treatment of overactive bladder, chronic fecal incontinence and non-obstructive urinary retention. The new smart programmer streamlines multiple devices into a single, intuitive, touch screen Samsung (SSNLF) mobile device and enables clinicians to personalize each patient’s care and allows patients to manage their therapy simply and discreetly. OAB and FI are treatable, extremely common and embarrassing conditions. More than 37M adults in the United States – almost one in six – suffer from OAB and nearly 20M Americans – about one in 12 – have bowel incontinence.
https://thefly.com/landingPageNews.php?id=2837933
Sunday, December 16, 2018
Eisai in Deal for Anti-Obesity Agent Lorcaserin in Brazil with Eurofarma
Eisai Co., Ltd. has entered into an agreement to grant exclusive development and marketing rights for its anti-obesity agent lorcaserin hydrochloride (generic name, product name in the United States: BELVIQ, product name for once-daily formulation in the United States: BELVIQ XR, “lorcaserin”) in Brazil to Eurofarma Laboratorios S.A. Under this agreement, Eisai will supply Eurofarma with lorcaserin. Eisai will receive a one-time contractual payment and is eligible for milestone payments for sales in Brazil.
In October 2018, Eisai signed an agreement to grant exclusive development and marketing rights for lorcaserin in 17 countries(1) in Latin America and the Caribbean, excluding Brazil.
Lorcaserin is an anti-obesity agent that is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. Lorcaserin was approved in 2012 by the U.S. Food and Drug Administration (FDA) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related co-morbid condition, and was launched in the United States in June 2013. Lorcaserin was approved in Brazil with the same indication as for the United States in December 2016.
By granting exclusive development and marketing rights for lorcaserin in Brazil to Eurofarma as well, Eisai aims to leverage Eurofarma’s strong business foundation throughout Latin America to accelerate the delivery of lorcaserin to more patients.
TAISHO said to near $1.6 billion deal for Bristol-Myers’s UPSA
Japanese healthcare firm Taisho Pharmaceutical Holdings Co Ltd is said to be close to a $1.6 billion deal for Bristol-Myers Squibb Co’s French over-the-counter drugs business UPSA, Bloomberg reported on Sunday, citing sources familiar with the matter.
An agreement for the consumer-health business could be announced as soon as this week, according to the report https://bloom.bg/2QyHulF.
Bristol-Myers Squibb said in an email to Reuters that it does not comment on rumors and speculation, adding that the company is still considering options for the strategic review of UPSA that was announced in June.
A Taisho spokesman said the company could not comment on the report.
German drugmaker Stada and Italian healthcare company Angelini were among the final bidders for Bristol-Myers’ UPSA unit, according to a Reuters report in November.
CARMAT Announces the Appointment of Pascale D’arbonneau as CFO
CARMAT (FR0010907956, ALCAR) (Paris:ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announces the appointment of Pascale d’Arbonneau as Chief Financial Officer.
A graduate of the ESCP Europe business school, Pascale d’Arbonneau is a member of the Association nationale des directeurs financiers et de contrôle de gestion, (DFCG, the French association of financial and management control managers) and a lecturer at Paris Diderot University. Before joining CARMAT, Pascale d’Arbonneau was Executive Director of the Econocom International B.V. (EIBV) family office.
She began her career in 1989 as an auditor at Coopers & Lybrand (now PWC) before entering the pharmaceutical industry as Head of Finance & IT France at Johnson & Johnson – MSD (1995-1999). She spent most of her career (1999-2016) at GlaxoSmithKline (GSK). She joined as Director, Head of Controlling & Finance Partnering, France at GlaxoWellcome, just before its merger with SmithKline Beecham, managing a team of 20 people working on the combination of the two companies. She then held a number of senior positions within the Group (Vice President & Finance Controller, Pharma Europe from 2006 to 2010, Vice President & Area Finance Director, Western Europe from 2010 to 2014) before becoming Vice President Compliance and Control Integration for all business units worldwide.
“I am delighted to join CARMAT at a time when the Company is preparing to reach major milestones in its development, to continue the excellent work accomplished thus far on both the financing front and the industrialization front. I look forward to working in collaboration with the team to put in place a detailed financial roadmap and accompany the Company’s growth”, says Pascale d’Arbonneau.
Stéphane Piat, Chief Executive Officer of CARMAT, adds: “It is a great pleasure to welcome Pascale d’Arbonneau to our management team. Her arrival marks the completion of the structuring of our Management Committee in view of the challenges ahead, and notably the finalization of the key stages in the CE marking process. Her unique expertise in finance and management control within major global healthcare groups will be essential to secure the ramping up of our project.”
FDA Action Alert: ADMA Biologics, Sage Therapeutics, Jazz
As the holidays approach, the U.S. Food and Drug Administration (FDA) is getting in a few drug approvals to wrap up the year. This week there are two decision dates, with another that has been delayed for several months. Here’s a look.
ADMA Biologics and its Bivigam
ADMA Biologics, with sites in Ramsey, NJ and Boca Raton, Fla., has a drug, Bivigam, which is an intravenous immune globulin indicated for the treatment of primary humoral immunodeficiency, which includes several diseases such as agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome and severe combined immunodeficiency. The FDA approved Bivigam on December 19, 2012, for Biotest Pharmaceuticals Corporation. In December 2016, Biotest stopped production. ADMA Biologics picked up all rights to Bivigam on June 6, 2017, when it acquired the Biotest Therapy Business Unit. ADMA then optimized the production process for Bivigam and submitted a Prior Approval Supplement to the FDA for the drug in June 2018. The FDA has a target action date of December 18 for Bivigam. If approved, ADMA plans to relaunch the drug for commercial sale in the first half of 2019.
Ligand Pharma and Sage Therapeutics’ NDA for IV-Brexanolone
In May, the FDA accepted Ligand Pharmaceuticals and SAGE Therapeutics’ New Drug Application (NDA) for SAGE-547, Sage’s lead product candidate. It is an intravenous formulation of brexanolone for the treatment of postpartum depression (PPD). The target action date is December 19, 2018.
On November 2, the FDA Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) jointly voted 17 to 1 in favor of the drug.
However, on November 20, the FDA extended the PDUFA date for its Priority Review of the NDA. At this point, the product is called Zulresso (brexanolone) injection. The date was moved to March 19, 2019. After the positive FDA Advisory Committee meeting, Sage submitted a proposed Risk Evaluation and Mitigation Strategies (REMS) program with Elements to Ensure Safe Use (ETASU) in response to the FDA’s request. The FDA chose, as it was allowed to do, to give itself another three months to consider the extra materials.
If approved, Zulresso will likely be scheduled by the U.S. Drug Enforcement Administration (DEA) consistent with other approved GABAergic therapies. The DEA will need to issue an interim final rule controlling the drug within 90 days of approval. As of right now, Sage is planning for a June 2019 launch if approved.
Sage licensed SAGE-547 from Ligand Pharmaceuticals.
Jazz Pharmaceuticals and Solriamfetol for Excessive Sleepiness
Jazz Pharmaceuticals has a target action date of December 20 for its NDA for solriamfetol for the treatment of excessive sleepiness in adults with narcolepsy or obstructive sleep apnea (OSA). The agency accepted the NDA on March 2, 2018.
Solriamfetol (JZP-110) is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) being developed for excessive sleepiness in patients with narcolepsy, OSA, and Parkinson’s disease. Jazz acquired the license to the drug from Aerial Biopharma in 2014. Jazz has worldwide development, manufacturing, and commercialization rights to the drug except for certain Asian jurisdictions. The discoverer of the drug, SK Biopharmaceuticals, maintains rights in 12 Asian markets, including Korea, China and Japan.
“We believe this medicine will provide a meaningful option for patients living with excessive sleepiness due to narcolepsy or OSA, and we look forward to working with the FDA during the review process for solriamfetol,” said Karen Smith, executive vice president, R&D and chief medical officer of Jazz, in a March statement. “Jazz continues to invest in ongoing research, education and advocacy on behalf of the sleep community, including studying solriamfetol for the treatment of excessive sleepiness in other areas of unmet need, such as Parkinson’s disease.”
Calyxt upgraded to Buy from Neutral at Goldman Sachs
Goldman Sachs upgrades Calyxt to Buy, saying underperformance presents opportunity as commercial sales approach.
https://thefly.com/landingPageNews.php?id=2837649
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