Smith & Nephew: FDA OKs removal of med warning as studies show safety

Smith & Nephew (LSE:SN, NYSE:SNN), the global medical technology business, announces that the U.S. Food and Drug Administration (FDA) has approved the removal of the boxed warning regarding increased rate of mortality secondary to malignancy from the prescribing information of REGRANEX gel.

This decision is based on an evaluation of multiple post-market studies that demonstrated no increased safety risk with the use of REGRANEX gel.^1,2 The boxed warning was added to the REGRANEX gel label in 2008 following an initial retrospective study using medical claims database. Smith & Nephew submitted data to the FDA to petition for the removal of the boxed warning, they included results from an extension of the initial retrospective study and two additional postmarketing studies.

The three-year extension of the initial retrospective study observed that the additional mortality data attenuated the earlier safety signal. A retrospective study using medical claims from the Veteran Affairs health care database of patients without prior cancer evaluated 6,429 REGRANEX gel users compared to 6,429 patients without REGRANEX gel treatment over 11 years and provided substantial evidence for no increased incident cancer or cancer mortality with REGRANEX gel use.

A second retrospective study using medical claims from the Veteran Affairs health care database of patients with prior cancer. The study evaluated patients with recently diagnosed malignancy in the prior one, two or three years before REGRANEX gel use compared to patients that did not receive REGRANEX gel over an 11-year study period. The rate of death due to cancer was similar in both groups and showed no evidence for increased risk of cancer death with the highest REGRANEX gel use.

REGRANEX gel is the first and only FDA-approved recombinant platelet-derived growth factor therapy for the treatment of lower extremity diabetic neuropathic ulcers. An estimated 15% of diabetics experience such diabetic foot ulcers in their lifetime. REGRANEX gel helps to heal these types of wounds an average of six weeks earlier than placebo gels, and is shown to provide a greater incidence of complete closure at 20 weeks compared to standard of care.²

https://www.marketscreener.com/SMITH-NEPHEW-9590181/news/Smith-Nephew-FDA-approves-removal-of-boxed-warning-from-REGRANEX-loz-becaplermin-gel-0-01-a-27709802/

Lower drug sales potential at Bayer underscores need for deals

Germany’s Bayer, which acquired seed company Monsanto this year, reduced its combined sales estimate for its most promising experimental drugs, acknowledging it needs to do more to replenish the development pipeline.

At its capital markets day in London on Wednesday, it said the tally of peak sales potential of its five most promising drugs was more than 3.75 billion euros (3.34 billion pounds), compared with a target of more than 6 billion euros for the top six drugs reiterated as recently as June.

Bayer last week announced the sale of a number of businesses, around 12,000 job cuts and 3.3 billion euros in impairments.

Bayer faces a threat to revenues in 2024 when the patent on blockbuster heart drug Xarelto runs out. Sales from eye drug Eylea, its second-best selling drug, are expected to suffer from competing drugs before that.

Bayer said it halted trials testing its experimental uterine fibroids treatment vilaprisan, which it previously expected to generate peak annual sales of more than 1 billion euros, citing the risk of side effects.

It also no longer included a peak sales estimate for anetumab ravtansine, a drug for asbestos-linked cancer type mesothelioma, previously seen generating more than 2 billion euros in annual revenues.

The group’s former head of pharmaceuticals, Dieter Weinand, said a year ago there was still hope for anetumab despite a setback in a Phase II trial in 2017, but Weinand quit and was replaced by Sanofi executive Stefan Oelrich last month.

Bayer added to the tally an annual peak sales potential of more than 750 million euros for larotrectinib against a variety of cancers driven by a rare genetic mutation. The drug, co-developed with Loxo Oncology, won U.S. market approval last week.

Bayer said in presentation slides that it plans to supplement its existing pipeline with in-licensing and bolt-on takeover deals.

“We need to fill our mid-term pipeline furthermore” over the next few years, Oelrich told investors at the event, adding that the early- and late-stage pipeline was strong.

Bayer also said it aimed to increase adjusted group core earnings to 16 billion euros (14.24 billion pounds) in 2022, up from an expected 12.2 billion euros this year, but that target does not yet take into account the planned divestment of its animal health unit or the effect of currency swings.

https://www.marketscreener.com/BAYER-436063/news/Lower-drug-sales-potential-at-Bayer-underscores-need-for-deals-27708003/?countview=0

OncoMed announces proposed combination of Mereo BioPharma

Mereo BioPharma Group, a clinical stage U.K. based biopharmaceutical company focused on rare diseases, and OncoMed Pharmaceuticals announce the proposed combination of Mereo and OncoMed. The transaction has been unanimously approved by the Board of Directors of each company. Subject to potential adjustment, based upon an OncoMed net cash balance of $38M at completion, current Mereo shareholders are expected to own approximately 75% of the issued share capital of the Enlarged Group, while current OncoMed shareholders are expected to own approximately 25% of the issued share capital of the Enlarged Group through their holding of ADRs. In addition, OncoMed shareholders will receive CVRs representing the right to receive future conditional cash payments and additional ADRs based on the achievement of certain milestones relating to OncoMed assets. The transaction is subject to customary closing conditions including, among other things, approval of the transaction by shareholders of OncoMed, the listing of the Mereo ADRs on NASDAQ and the admission to trading of the Ordinary Shares to be issued in connection with the Transaction on AIM. Mereo’s CEO Denise Scots-Knight said: “I am delighted to announce our proposed combination with OncoMed. The Transaction allows us to broaden our asset base, including strengthening our cash position to enable us to progress beyond our key clinical milestones. We believe that our plan to initiate a US ADR programme on NASDAQ, in addition to the continued listing of our ordinary shares on AIM, will facilitate a deep engagement with the broadest range of appropriate investors. During 2019 we continue to expect several value inflection points, including data from our Phase 2b dose ranging study for BPS-804 for osteogenesis imperfecta and data from our Phase 2 dose ranging study for MPH-966 for alpha-1 antitrypsin deficiency both being run in the US and Europe. Alongside these milestones, we are also progressing partnering discussions for our other two products, BCT-197 for acute exacerbations of COPD and BGS-649 for hypogonadotropic hypogonadism. We also intend to begin partnering discussions for OncoMed’s navicixizumab programme, which has generated encouraging clinical data in ovarian cancer that should guide further clinical development.”

https://thefly.com/landingPageNews.php?id=2832451

Exelixis, Ipsen initiate Phase 3 COSMIC-312 trial

Exelixis (EXEL) and Ipsen (IPSEY) announced the initiation of COSMIC-312, a phase 3 pivotal trial of cabozantinib versus sorafenib in previously untreated advanced hepatocellular carcinomaThe co-primary endpoints of the trial are progression-free survival and overall survival. An exploratory arm will also evaluate cabozantinib monotherapy in this first-line setting. COSMIC-312 is a multicenter, randomized, controlled phase 3 pivotal trial that aims to enroll approximately 640 patients at up to 200 sites globally. Patients will be randomized 6:3:1 to one of three arms: cabozantinib and atezolizumab, sorafenib, or cabozantinib. Exelixis is sponsoring COSMIC-312, and Ipsen will co-fund the trial. Ipsen will have access to the results to support potential future regulatory submissions outside of the U.S. and Japan. Genentech, a member of the Roche Group, is providing atezolizumab for use in this trial.
https://thefly.com/landingPageNews.php?id=2832369

Tesaro downgraded to Neutral from Overweight at Cantor Fitzgerald

Tesaro downgraded to Neutral from Overweight at Cantor Fitzgerald. Cantor Fitzgerald analyst Young downgraded Tesaro (TSRO) to Neutral to reflect the takeover by GlaxoSmithKline (GSK). The analyst raised her price target for the shares to $75 from $68.

https://thefly.com/landingPageNews.php?id=2832381

Cytokinetics announces initiation of Phase 1 trial of CK-3773274

Cytokinetics announced the first subject has been dosed in a Phase 1 double-blind, randomized, placebo-controlled, multi-part, single and multiple ascending dose clinical trial of CK-3773274 in healthy adult subjects. CK-274 is a novel cardiac myosin inhibitor, discovered by company scientists, in development for the potential treatment of hypertrophic cardiomyopathy. Fady Malik, Cytokinetics’ Executive VP of Research & Development, said, “Our scientists pioneered this emerging area of muscle pharmacology and have now advanced a next-generation drug candidate that was optimized for pharmacokinetic properties and therapeutic index. This first trial will elaborate on CK-274 and its potent

https://thefly.com/landingPageNews.php?id=2832419

Bausch Health reports FDA clearance for ULTRA Multifocal for Astigmatism lenses

Bausch + Lomb, a wholly owned subsidiary of Bausch Health Companies, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for Bausch + Lomb ULTRA Multifocal for Astigmatism contact lenses, which it said is the first multifocal toric lens to be available as a standard offering in the eye care professional’s fit set. “The most advanced soft contact lens design in the history of Bausch + Lomb, this monthly silicone hydrogel lens builds upon the success of Bausch + Lomb ULTRA for Presbyopia and Bausch + Lomb ULTRA for Astigmatism lenses,” the company stated. Bausch Health anticipates Bausch + Lomb ULTRA Multifocal for Astigmatism will be available to eye care professionals and their patients by mid-2019.
https://thefly.com/landingPageNews.php?id=2832443