Pfizer responds to regulators after reinspections of injected painkiller plant

Pfizer says it has made significant strides in upgrading the sterile injectables plant where it manufactures many of its generic painkillers but acknowledges more must be done after reinspections by the FDA and other regulators.

The FDA, along with teams from the European Medicines Agency and the Health Canada, concluded reinspections this month at the plant in McPherson, Kansas, that has been at the heart of shortages at U.S. hospitals of injected painkillers. Pfizer its is responding to observations about some of the plant’s “practices and processes,” according to an internal Pfizer memo obtained and posted by STAT.

“Although we have demonstrated improvement in many areas, we are still on a journey to drive further improvement and meet our commitments to both our regulators and our patients,” site leader Carole Johnson told employees in the memo.

The FDA last year issued a warning letter to the former Hospira plant where Pfizer produces a broad portfolio of generic sterile injectables, as well as does contract work for clients. The problems derailed approval of Sandoz’ and Momenta’s generic of Teva blockbuster Copaxone, for example. The drug was approved earlier this year after the FDA found enough improvement at the plant to upgrade the status to Voluntary Action Indicated (VAI).

Pfizer today in an email said that while production at some modules at the plant was interrupted while new HEPA filters were installed, “The vast majority of site operations was not impacted. The site has operated continuously since the last plant maintenance period in the first quarter of 2018.”

Still, because the plant is responsible for so much of the country’s injectables painkiller supply, production interruptions have left hospitals scrambling for supplies to provide routine patient care. The amount of opioids that any company can produce is determined by the Drug Enforcement Agency. While Pfizer this spring resumed production of those products, the DEA gave some of its narcotics quota to competitors to address ongoing shortages.

Pfizer also stopped shipments of injected painkillers to veterinarians and said it won’t resume sales for animal use until the shortage at hospitals and surgical facilities has been resolved, which is not expected before the second quarter of 2019.

https://bit.ly/2N086pE

Medtronic reports Q1 adjusted EPS $1.17, consensus $1.11

Reports Q1 revenue $7.4B, consensus $7.24B.

https://bit.ly/2N5gnsB

Tilray Agrees with Ontario Cannabis Retail Corp. to Supply Cannabis Products

Tilray Canada Ltd. (“Tilray”), a wholly owned subsidiary of Tilray, Inc. (Nasdaq: TLRY) announced today that the company has signed an agreement with the Ontario Cannabis Retail Corporation (“OCRC”), operating as the Cannabis Retail Store (“OCS”) to supply the province of Ontario with a diverse array of cannabis products in anticipation of the launch of the adult-use market on October 17, 2018. Tilray intends to fulfill the agreement through its affiliate High Park Holdings Ltd., DBA High Park Company™ (“High Park”), which was formed to produce and distribute a broad-based portfolio of adult-use cannabis brands and products.

“We are thrilled to partner with the OCS as a reliable supplier for safe and secure cannabis to Ontario,” said Adine Fabiani-Carter, Chief Marketing Officer at High Park. “Our goal is to deliver on the high expectations that Ontarians have of us by cultivating and distributing a portfolio of world-class adult-use brands and products that will lead the market in quality, excellence and craftsmanship.”

Tilray’s agreement with the OCS includes an initial offering of world-class brands in Ontario that include:

Marley Natural®, crafted with deep respect for wellness and the positive potential of the herb, Marley Natural offers four categories of cannabis whole-flower and pre-rolls; Marley Green (hybrid), Marley Gold (sativa), Marley Red (high-CBD) and Marley Black (indica).

Irisa™, a women’s wellness brand, offering a collection of thoughtfully crafted cannabis products including pre-rolls, sublingual drops and massage oil.

CANACA™, offers the best of Canadian bud in a variety of celebrated cannabis strains available in whole-flower and pre-rolls.

Each brand in the portfolio is uniquely crafted and grown by master horticulturists dedicated to sustainable growing practices, and each of these brands are expected to be made available in Ontario through online sales starting October 17, 2018, the anticipated date of launch for adult-use cannabis products in Ontario.

https://bit.ly/2OQ9zzy

Canopy Growth secures over 100 product listings in Ontario

Canopy Growth Corporation (TSX: WEED) (NYSE: CGC) (the “Company” or “Canopy Growth”), through its wholly-owned subsidiary Tweed Inc., has been selected as an approved supplier by the Ontario Cannabis Store (“OCS”) to supply a wide variety of cannabis products through its online store starting October 17th, 2018.

Specific quantities will be disclosed once those details have been released by the province. In total, Tweed has successfully listed over 100 cannabis SKUs across multiple formats including pre-rolled joints, dried flower, oils, and softgel capsules.

“Today marks another significant milestone for us as we’ve officially ensured Ontarians will have access to a huge variety of Tweed-branded products,” said Mark Zekulin, President & Co-CEO, Canopy Growth. “With our private retail plan being rolled out in other provinces, our attention in Ontario will now turn to bricks and mortar shops in this key market.”

Canopy Growth applauds the Province of Ontario’s recent decision to initiate a private cannabis retail network. It is an incredible opportunity that will see the private sector make investments around the province, reducing taxpayer dollars spent while maintaining a smart, centralized warehouse inventory system.

Private retail is a more profitable business model which will also allow Tweed to build a deeper connection with its customers.

Every detail of Tweed’s retail stores, from the backend point of sale and loss prevention systems to the fixtures on the walls, have been finalized. With the prep work complete, Tweed stores can be opened within weeks of receiving the green light.

With today’s announcement Canopy Growth continues its streak of being included in every province and territory’s supply plans. Canopy Growth is a proudly Canadian company with a truly national presence, Coast to Coast to Coast.

https://bit.ly/2PpZJ8s

NMC HEALTH expands IVF reach after acquisition

GLOBAL healthcare operator NMC Health has expanded its fertility services into the UKafter acquiring one of the country’s biggest private hospital providers.

Shares rose by as much as five per cent in trading yesterday after the UAE-focused company announced details of its further expansion into Europe and Africa and its half-year results showed profits had risen 19 per cent to $116.7m (£91.4m).

The company said it had acquired Aspen Healthcare from Tenet Healthcare for £10m.

Aspen operates nine facilities across the UK, including four hospitals – three of which, Parkside Hospital, The Holly Private Hospital and Highgate Hospital, are in Greater London.

NMC said the acquisition would provide a cost-effective means of introducing its IVF fertility services to the UK.

It has also expanded its fertility services into Sweden and Latvia – opening new IVF clinics – and added a fourth continent to its global reach by launching a clinic in Kenya.

Chief executive, Prasanth Manghat, said the acquisition and expansions were part of a new strategy set out in December and had a positive outlook for the rest of the year.

He said: “Despite the passage of a relatively short time period since outlining the enhanced strategy, we have made substantial progress across all facets.

“We continue to expand into new geographies.”

https://bit.ly/2MDWRGw

AstraZeneca: Lung cancer med label extended in Japan

AstraZeneca today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Tagrisso (osimertinib) for the 1st-line treatment of patients with inoperable or recurrent epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC), following priority review. The approval is based on results from the global Phase III FLAURA trial which included Japanese patients and which were published in the New England Journal of Medicine.

Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit, said: ‘Tagrisso is already approved in Japan for the treatment of patients with EGFR T790M mutation-positive inoperable or recurrent NSCLC that is resistant to existing 1st-line EGFR-inhibitor medicines. Today’s approval moves the use of Tagrisso to the 1st-line setting, replacing older medicines which, given the high prevalence of the EGFR mutation in Japan, offers an important new treatment option for these patients.’

The FLAURA trial compared Tagrisso to current 1st-line EGFR tyrosine kinase inhibitors (TKIs), erlotinib or gefitinib in previously-untreated patients with locally-advanced or metastatic EGFR-mutated (EGFRm) NSCLC. In the trial, Tagrisso demonstrated superior progression-free survival (PFS) of 18.9 months compared with 10.2 months for the comparator arm (see table below), and this benefit was consistent across all subgroups including in patients with or without central nervous system (CNS) metastases, an important benefit for lung cancer patients.

https://bit.ly/2N57RK2

Neurocrine to present Phase 3 data from Parkinson’s trial

Neurocrine Biosciences, Inc.(NASDAQ: NBIX) today announced it will present data from its movement disorders programs, including additional long-term results for INGREZZA(valbenazine) capsules, the first U.S. Food and Drug Administration (FDA) approved treatment for adults with tardive dyskinesia (TD), and data analyses from a Phase III study on opicapone, an investigational treatment for Parkinson’s disease.

These results will be presented at the 2018 World Congress on Parkinson’s Disease and Related Disorders (IAPRD) in Lyon, France, Aug. 19-22, 2018.

‘Neurocrine Biosciences is committed to bringing innovative and effective treatments to patients living with movement disorders,’ said Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine Biosciences. ‘We look forward to providing additional analyses of INGREZZA’s long-term efficacy in tardive dyskinesia, as well as findings from the Phase III BIPARK-I study of opicapone in Parkinson’s disease. We believe these results will help healthcare providers further understand the benefits of INGREZZA and the potential of opicapone to help patients suffering from these serious, and often isolating, movement disorders.’

Highlighted poster presentations on INGREZZA include data from two long-term studies examining the treatment’s safety and efficacy over 48 weeks in patients with tardive dyskinesia, including patient-reported outcome results from the Phase III KINECT 4 study and an open-label, rollover trial reporting on symptom improvement and patient satisfaction with treatment.

Neurocrine will also present three analyses on opicapone from the Phase III BIPARK-I study highlighting the efficacy and safety of once-daily opicapone treatment in patients with Parkinson’s disease, compared to placebo and entacapone. Primary outcomes from the BIPARK-I study were previously published in Lancet Neurology, with the outcomes from the open-label extension phase of the BIPARK-I study subsequently published in Neurology.

https://bit.ly/2nW85s0