Henkel says looking at M&A, no comment on Nestle

German consumer goods group Henkel is scanning the market for takeovers, its chief financial officer told a paper, declining to say whether it was looking at Nestle’s skin health unit that was put up for sale earlier this week.

“We continue to see acquisition potential,” Carsten Knobel told Boersen-Zeitung in an interview published on Saturday. “We have defined, and implemented, M&A as an integral part of our strategy in our current strategy cycle.”

Nestle said on Thursday it was exploring strategic options for Nestle Skin Health, which makes Cetaphil and Proactiv skin care brands, with analysts estimating its value at up to 8 billion Swiss francs (£6.4 billion).

“I do not want to comment on that,” Knobel said when asked whether Henkel was looking at the division.

Henkel’s M&A activity has been muted so far this year after the group spent close to 2 billion euros (£1.8 billion) on takeovers in 2017, something Knobel blamed on high valuations.

“Prices are not cheap, but that’s not the only decisive factor. For us it is key whether the target is available, whether there is a strategic fit and whether it is financially attractive. If so, we’ll acquire.”

https://www.marketscreener.com/NESTLE-9365334/news/Nestle-Henkel-says-looking-at-M-A-no-comment-on-Nestle-Boersen-Zeitung-27302147/

vTv says FDA advised that azeliragon efficacy be shown in at least 2 trials

According to a regulatory filing, on September 17, 2018, vTv Therapeutics Inc. received a written response from the FDA to its Type C Meeting Request seeking development guidance for azeliragon. In the response, the FDA advised that the efficacy of azeliragon should be demonstrated in at least two adequate and well-controlled trials, unless under the exceptional circumstances in which a single trial might suffice as set forth in the FDA’s guidance document entitled “Providing Clinical Effectiveness for Human Drug and Biological Products.” The company continues to assess all options for the continued development of azeliragon.

https://thefly.com/landingPageNews.php?id=2794068

‘Good time’ to think about device markers, Barron’s says

Medical technology stocks have reached their highest valuations in decades, but unlike some sectors, shares might stay aloft, Bill Alpert writes in this week’s edition of Barron’s. Hot performers among medical-device stocks this year include Boston Scientific (BSX) and Intuitive Surgical (ISRG), each up 50%, the report notes, adding that med tech trades at a premium given its double-digit sales growth and scarcity
https://thefly.com/landingPageNews.php?id=2794099

Equillium Plans $86M IPO to Fund Clinical Trials for Transplant Drug

Equillium, a biotech startup developing treatments for immune system disorders—including an immune response that affects some transplant recipients—is preparing for an IPO to finance tests of its lead drug.

The company set a preliminary IPO target of $86 million, according to documents filed this week with securities regulators, and has applied to be listed on the Nasdaq exchange under the stock symbol “EQ.”

La Jolla, CA-based Equillium, founded in 2017 (originally as Attenuate Biopharmaceuticals), licensed its antibody drug candidate itolizumab (which it calls EQ001) from Biocon Limited (NSE: BIOCON), India’s largest biopharmaceutical company. Itolizumab has been approved in India to treat plaque psoriasis, an autoimmune skin condition. Biocon markets the drug there for patients with active moderate to severe forms of the disease as ALZUMAb.

Equillium plans to test the drug for multiple immuno-inflammatory diseases—asthma, uveitis, colitis, and multiple sclerosis—characterized by attacks by the body’s immune system. Its lead target is graft-versus-host disease, an immune response that affects some transplant patients.

“We believe EQ001 may have broad therapeutic utility in treating a large and diverse set of severe immuno-inflammatory diseases,” the company said in its prospectus filed Monday.

Equillium chairman and CEO Dan Bradbury (pictured above) previously headed another La Jolla drug maker, the diabetes drug manufacturer Amylin Pharmaceuticals, which was founded in 1987.

Bradbury, who worked at Amylin for 18 years, was CEO from 2007 to 2012, when the company was jointly acquired for $5.3 billion, plus $1.7 billion in Amylin debt, by New York-based pharmaceutical company Bristol-Myers Squibb (NYSE: BMY) and AstraZeneca (NYSE: AZN).

The acquisition followed the regulatory approval of Amylin’s drug Bydureon, a once-per-week diabetes shot.

Bristol later sold its stake in Amylin to AstraZeneca, shuttered the San Diego company’s operations and elsewhere, and folded its personnel into its other operations.

Prior to his time at Amylin, Bradbury spent 10 years with GlaxoSmithKline (NYSE: GSK) predecessor SmithKline Beecham Pharmaceuticals in marketing and sales.

Equillium said it intends to use about $50 million in IPO proceeds to fund research and development of EQ001, specifically a Phase 1b/2 clinical trial for the acute form of GVHD in early 2019, and a Phase 2 clinical trial for the chronic version of the disease and a proof-of-concept clinical trial for the treatment of severe asthma in the first half of 2019.

While EQ001 and ALZUMAb share the same antibody, Equillium notes each is manufactured in different cell lines, meaning they could be considered different biopharmaceutical products.

Equillium sources the antibody through its partnership with Biocon, which the biopharma giant manufactures for clinical and commercial use. No FDA-approved therapies currently target CD6, the receptor Equillium is targeting, although some independent studies have validated CD6 as a target, the company noted in its filing.

Equillium, of course, is far from alone in its interest in developing treatments for diseases involving the immune system. Just over a year ago the FDA approved ibrutinib as the first drug for use in patients with chronic GVHD. Marketed as Imbruvica, the treatment was developed by Pharmacyclics, a Bay Area-based biopharma company owned by AbbVie (NYSE: ABBV).

Bradbury co-founded Equillium with Bruce Steel, who is president and chief business officer, and Stephen Connelly, the chief scientific officer.

Steel is also founder and managing director of BioMed Ventures, the strategic investment arm of BioMed Realty; Connelly is a BioMed Ventures principal. Connelly was previously director of business development and therapeutic alliances at San Diego’s aTyr Pharma (NASDAQ: LIFE), which went public, raising $75 million, in 2015.

Prior to co-founding Equillium, Steel was co-founder and CEO of Rincon Pharmaceuticals, which was acquired in 2008 by bioenergy startup Sapphire Energy.

The trio are the company’s principal stockholders—Bradbury and Steel each own about one-third, while Connolly owns about one-tenth—along with Biocon SA, a Biocon subsidiary, which owns an 18.8 percent stake.

As of June 30, Equillium had raised $9.4 million in convertible notes and had $6.6 million in cash and cash equivalents on hand. It reported a net loss since inception of $5.6 million. The IPO proceeds, plus its existing funds, would pay for operations for “at least” the next 24 months, Equillium said.

https://www.xconomy.com/san-diego/2018/09/21/equillium-plans-ipo-to-fund-clinical-trials-for-transplant-drug/

Cannabinoid Trials Needed for Peds Neurologic Disorders

There is an urgent need for clinical trials to investigate the use of cannabinoids in pediatric patients with neurological disorders, according to a commentary published in the Aug. 27 issue of CMAJ, the journal of the Canadian Medical Association.

Parents use unregulated cannabinoids to manage neurological disorders in children, including seizures, spasticity, and irritability in children with epilepsy, autism-spectrum disorder, and cerebral palsy. Yet, the decision to treat is often made based on only a small series of case reports and anecdotal online accounts.

Lauren E. Kelly, Ph.D., from the University of Manitoba in Winnipeg, and Anne Junker, M.D., from the British Columbia Children’s Hospital in Vancouver — both in Canada, write that clinical trials are needed to determine the safety and effectiveness of cannabinoids and to guide dosing in children with neurological conditions. The authors urge that clinical trial design considerations include prospective planning, innovative methods, parent engagement, and multisite collaboration. Additionally, they should incorporate long-term neurodevelopmental follow-up.

“It is time to move away from the ‘era of the anecdote’ and toward evidence-informed selection and dosing of cannabinoids in children,” the authors write.

Abstract/Full Text (subscription or payment may be required)

http://www.physiciansbriefing.com/Article.asp?AID=737664

AI Aids in Identifying Breast Cancer Tumors

Molecular markers of breast cancer tumors can be identified by focusing on parameters of a cell’s nucleus, and aided by machine learning, according to a study published online Sept. 4 in npj Breast Cancer.

Rishi R. Rawat, from the University of Southern California in Los Angeles, and colleagues introduced a machine learning framework to identify relationships between cancer tissue morphology and hormone receptor pathway activation in breast cancer pathology samples stained with hematoxylin and eosin (H&E). The authors focused on predicting clinical estrogen receptor (ER) status from the spatial arrangement of nuclear features as a proof-of-concept. To predict ER status, the learning pipeline extracted parameters describing the position, shape, and orientation of the nuclei from H&E images, and passed them to a deep neural network.

The researchers found that the pipeline predicted ER status in an independent test set of 56 patient samples after training on 57 tissue cores of invasive ductal carcinoma (area under the receiver operator characteristic curve, 0.72). Machine-derived descriptors of morphologic histology patterns were correlated to signaling pathway status.

“We can use this technology to identify the molecular markers of the tumor and in the future will identify which therapeutics the tumor will respond to,” Rawat said in a statement. “Machine learning helps us get this information to patients sooner and may transform cancer care in the developing world where precise breast cancer marker assessment is in short supply.”

Abstract/Full Text (subscription or payment may be required)

http://www.physiciansbriefing.com/Article.asp?AID=737550

AbbVie Gets Euro Panel Nod for Chronic Lymphocytic Leukemia Combo

– If approved by the European Commission (EC), VENCLYXTO® plus rituximab would be the first chemotherapy-free combination regimen with a fixed duration of treatment for patients with chronic lymphocytic leukemia who have received at least one prior therapy.
– The positive opinion is based on the MURANO Phase 3 clinical trial, in which VENCLYXTO plus rituximab met the primary endpoint of prolonged progression-free survival and the majority of patients achieved undetectable minimal residual disease in the peripheral blood, compared to a standard of care chemoimmunotherapy regimen of bendamustine plus rituximab.[1]
– The safety profile of the combination of VENCLYXTO plus rituximab is consistent with the known safety profile of each medicine alone.[1]   

AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for VENCLYXTO^® (venetoclax tablets) in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) who have received at least one prior therapy. The positive CHMP opinion is a scientific recommendation for marketing authorization to the European Commission (EC), which will deliver its final decision, valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.

In 2016, VENCLYXTO was approved by the EC as a monotherapy for the treatment of R/R CLL in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, and for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor. If approved by the EC, VENCLYXTO plus rituximab could be prescribed to a broader patient population with R/R CLL than the currently approved indication for VENCLYXTO monotherapy in the EU.

“This positive CHMP opinion is one important step forward as AbbVie continues to further the research and development of novel medicines with the potential to transform the standard of care in blood cancers,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “The combination of VENCLYXTO with rituximab has the potential to give patients with relapsed/refractory chronic lymphocytic leukemia a chance to live longer without their disease progressing, and to stop treatment after their two-year course.”

The CHMP positive opinion is based on results from the MURANO Phase 3 clinical trial, which evaluated the efficacy and safety of VENCLYXTO in combination with rituximab compared with bendamustine in combination with rituximab. At the time of the primary analysis, the trial demonstrated a statistically significant improvement in investigator-assessed progression-free survival (PFS; the time on treatment without disease progression or death²) for patients who received VENCLYXTO plus rituximab compared with bendamustine plus rituximab.

https://www.biospace.com/article/abbvie-receives-positive-chmp-opinion-for-a-novel-chemotherapy-free-combination-of-venclyxto-venetoclax-tablets-with-rituximab-as-a-treatment-with-a-fixed-duration-for-patients-with-chronic-lymphocytic-leukemia/