STAAR Surgical to Launch New Permanent Contact Lens for Astigmatism

Parkhurst NuVision, a San Antonio, Texas-based vision correction facility, has been chosen to perform the highly anticipated national launch of a new permanent contact lens for myopia and astigmatism in one. Dr. Greg Parkhurst will be the first surgeon in the nation to offer the Visian toric ICL to his patients in November 2018. The Visian Toric ICL, a variant of Visian ICL technology created by STAAR Surgical, has been approved by the FDA and allows surgeons to treat astigmatism while simultaneously correcting vision.

The Visian ICL represents a permanent contact lens that has been available for over a decade. The procedure has helped hundreds of thousands of patients enjoy life free from glasses or contacts. However, it has not been a particularly good option for patients with significant astigmatismuntil now, says Greg Parkhurst, MD, a leading San Antonio LASIK specialist and one of the most experienced Visian surgeons in America. With the FDA-approved Visian Toric ICL, surgeons will now be able to use this excellent procedure to treat moderate and even high astigmatism during the vision correction process.

The Visian technology is similar to LASIK in that it is a long-term vision correction solution. During LASIK, the shape of the eyes surface (cornea) is changed to correct the patients vision. The Visian is made of a collagen co-polymer, similar to collagen in the rest of the body, so it is biocompatible. The permanent contact lens is placed just beneath the surface of the eye to achieve vision correction.

The FDAs approval of STAAR Surgicals Visian Toric ICL in the U.S. provides an intuitive treatment option for myopic patients with astigmatism in search of visual freedom, adds STAAR Surgicals President and CEO Caren Mason. We are thrilled to be offering this lens in the United States, and look forward to officially making the Visian Toric ICL available to U.S. surgeons for their patients.

https://www.marketscreener.com/STAAR-SURGICAL-COMPANY-10951/news/STAAR-Surgical-Parkhurst-NuVision-to-Perform-Highly-Anticipated-National-Launch-of-New-Permanent-C-27302280/

Bayer: Jivi Approved in Japan for Hemophilia a

Bayer announced today that the Japanese Ministry of Health, Labour and Welfare(MHLW) has approved Jivi(R) (BAY94-9027) for the prophylactic treatment of hemophilia A for adults and adolescents 12 years of age or older in Japan. The recommended usual dose for prophylactic regimens is twice weekly. Jivi can also be dosed once every 5 days or once a week in accordance with the patient’ conditions. Jivi is also approved for on-demand treatment and perioperative management of surgeries. Jivi is a site-specifically PEGylated recombinant Factor VIII (rFVIII) that delivers higher sustained levels of FVIII, which extends the blood’s ability to coagulate for longer.

“Nowadays, people with hemophilia can lead their daily lives with less worry thanks to factor VIII replacement therapies,” said Dr.Teruhisa Fujii, director of the Blood Transfusion Division at the Hiroshima University Hospital. “The approval of Jivi allows certain patients with hemophilia A to preserve coagulation factor levels to prevent bleeding with just one infusion per week. This represents an important improvement, allowing patients more flexibility in their lifestyles.”

“The MHLW approval makes Jivi available to patients with hemophilia A in Japan with an option for once weekly dosing dependent on patients’ individual needs. Jivi can be dosed flexibly based on their previous bleed episodes, whilst maintaining protection from bleeds across all approved regimens,” said Dr. Joerg Moeller, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development. “Therefore, this approval is an important step forward for people with hemophilia A in Japan. This is the second major approval for Jivi this year following FDA approval in the U.S. in August.”

https://www.marketscreener.com/BAYER-436063/news/Bayer-Jivi-Approved-in-Japan-for-Hemophilia-a-27302159/

Bayer Receives Positive CHMP Opinion for Its Hemophilia a Treatment

Bayer announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended BAY94-9027 for the marketing authorization for treatment and prophylaxis of bleeding in previously treated patients 12 years of age or older with hemophilia A. The CHMP recommendation is based on results from the Phase 2/3 PROTECT VIII trial. BAY94-9027 recently received FDA approval in the U.S. where it is marketed under the brand name Jivi(R).

“For physicians treating hemophilia A patients with a range of individualized needs, it is important to have the opportunity to offer a treatment which delivers sustained levels of Factor VIII in the blood and thus providing good bleed protection,” said Prof. Dr. Oldenburg, Director of the Hemophilia Centre at the University Clinic in Bonn, Germany. “BAY94-9027 was engineered to have an extended half-life by harnessing proven PEG-technology, which could extend the blood’s ability to coagulate for longer.”

“BAY94-9027 is a uniquely designed recombinant Factor VIII molecule that has demonstrated efficacy and a good safety profile with the potential for reduced injection frequency in adults and adolescents,” said Dr. Joerg Moeller, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development. “After the approval of BAY94-9027 in the U.S., the positive CHMP recommendation is an important step forward for people with hemophilia A in the European Union. Bayer has also submitted marketing authorization applications for BAY94-9027 in other countries.”

https://www.marketscreener.com/BAYER-436063/news/Bayer-Receives-Positive-CHMP-Opinion-for-Its-Hemophilia-a-Treatment-BAY94-9027-27302161/

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/