Roche blaming Irish Government deal for revenue decline

The main Irish arm of Roche, the Swiss pharma giant, has blamed a new pricing agreement with the Government for “a significant decline in revenues” at the company in 2017.

That is according to new accounts filed by Roche Products (Ireland) Ltd which show that the company`s pre-tax profits last year declined by 7pc to 5m.

This followed revenues declining by 6pc from 108.96m to 101.69m during 2017. The firm paid a dividend of 2.5m in 2017.

According to the directors` report “2017 proved to be a difficult trading year for the company with a significant decline in revenues”.

On the factors leading to the decline in revenues, the directors state the company “felt the full-year impact of the new pricing agreement between the Irish Pharmaceutical Healthcare Association (IPHA) and the Department of Health which was signed in July 2016”.

They add that the impacts “were a combination of lower list prices and increased rebates to the State”.

The directors state “like other IPHA members, the company continued to experience significant delays in the re-imbursement of medicines”.

The directors also stated that one of the firm`s cancer drugs, Mabthera, became subject to biosimilar competition.

They said: “Under the pricing agreement, the company had to reduce the price to the State of Mabthera to 70pc of its original price. On top of this, we also lost volume share to the biosimilar.”

The directors state that the continued delay in the re-imbursement of innovative new medicines “is a cause of concern for the company, both in terms of planning and the ability to deliver life-changing medicines to patients in Ireland”.

They say that, despite these challenges, the directors remain cautiously optimistic for the future with a strong pipeline of new medicines for the treatment of haemophilia, lung cancer and multiple sclerosis among others.

They state: “However, revenue is expected to drop further in 2018 due to further price cuts and increased competition from biosimilars.”

https://www.marketscreener.com/ROCHE-HOLDING-68997/news/Roche-is-blaming-Government-deal-for-revenue-decline-27779230/

Genmab: EC OKs DARZALEX (daratumumab) Split Dosing Regimen

• Split dosing regimen approved by European Commission
• Provides healthcare professionals with option to split first DARZALEX infusion over two consecutive days
• Approval supported by data from EQUULEUS (MMY1001) clinical trial

Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the European Commission (EC) has granted marketing authorization for a split dosing regimen for DARZALEX^®(daratumumab).  The approval will be included in an update of the Summary of Product Characteristics in order to provide health care professionals the option to split the first infusion of DARZALEX over two consecutive days. The EC approval follows a positive opinion issued for DARZALEX by the European Committee for Medicinal Products for Human Use (CHMP) on November 18^th, 2018. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

“We are hopeful that the availability of this more flexible dosing option will make the first infusion of DARZALEX more convenient for European multiple myeloma patients,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

This approval was based on data from the Phase Ib EQUULEUS (MMY1001) clinical trial, which demonstrated DARZALEX pharmacokinetics (PK) concentrations were comparable regardless of whether the first dose was administered as a split infusion or as a single first infusion in patients with multiple myeloma. The safety profile of DARZALEX was comparable when administered initially as either a split or a single dose.

https://www.marketscreener.com/GENMAB-1412914/news/Genmab-Announces-European-Commission-Approval-of-DARZALEX-daratumumab-Split-Dosing-Regimen-27779924/

ADMA Biologics provides regulatory update on Bivigam PAS submission

ADMA Biologics announced that the FDA has issued a Complete Response Letter for the drug substance Prior Approval Supplement submission and previously approved the drug product PAS submission. The FDA approved ADMA’s drug product PAS submission which was comprised of fill, finish and final release information of the drug product. The FDA issued a CRL to ADMA pertaining to only the drug substance PAS submission which pertains to chemistry, manufacturing and controls information. In the CRL, the FDA did not request any information pertaining to compliance status, clinical study safety and efficacy. The company believes the FDA comments to the drug substance PAS submission are “addressable and resolvable”. The company will request a meeting with the FDA to provide the FDA with clarification and responses to the issues raised in the CRL.

https://thefly.com/landingPageNews.php?id=2839624

Alcon Announces Acquisition of Tear Film Innovations

Alcon, the global leader in eye care and a division of Novartis, today announced that it has acquired Tear Film Innovations, Inc. (“Tear Film”), a privately-held company and manufacturer of the iLux^® Device, an innovative therapeutic device used to treat Meibomian Gland Dysfunction, a leading cause of dry eye.

Handheld and portable, the iLux^® Device enables eye care professionals to directly target a patient’s blocked meibomian glands and provide therapy through an in-office treatment. Using the iLux^® Device, a practitioner can warm the eyelids via disposable silicone pads to address blocked meibomian glands through the application of light-based heating. While applying the iLux^® Device, the practitioner can view the eyelid margin and apply manually-controlled compression to express blockages, making adjustments as needed to tailor treatment to the individual needs of the patient. Most treatments can be completed in a matter of minutes.

The Tear Film acquisition expands Alcon’s leading portfolio of ocular health products, including several leading treatments for the temporary relief of dry eye symptoms.

“With the acquisition of Tear Film, we’re excited to bring this latest innovation to treat the millions of people around the world who suffer from dry eye,” said Andy Pawson, Alcon President & General Manager, Global Vision Care Franchise. “Alcon remains committed to improving the lives of patients around the world through innovative technologies like the iLux^® Device to address significant unmet needs in eye care.”

The iLux^® Device received 510(k) clearance from the U.S. Food and Drug Administration in December 2017, and was officially launched by Tear Film in May 2018 at the annual meeting of the American Society for Cataract and Refractive Surgery.

“Since launching the iLux^® Device earlier this year, we’ve seen an enthusiastic response from eye care professionals who have already begun to incorporate it as an advanced treatment option for patients suffering from Meibomian Gland Dysfunction,” said Rob Thornhill, CEO of Tear Film. “Now, as part of Alcon, we’re eager to bring this technology to even more offices throughout the world.”

The iLux^® Device is currently available in the U.S. and Canada. Alcon expects to announce plans to expand to other countries in 2019.

https://www.biospace.com/article/alcon-announces-acquisition-of-tear-film-innovations-inc-/

Teledyne to Acquire Scientific Imaging Businesses of Roper Technologies

 Teledyne Technologies Incorporated (NYSE:TDY) (“Teledyne”) and Roper Technologies, Inc. (NYSE:ROP) (“Roper”) jointly announced today that they have entered into a definitive agreement under which Teledyne will acquire the Scientific Imaging businesses of Roper for $225 million in cash. The Scientific Imaging businesses include Princeton Instruments, Photometrics and Lumenera, as well as other brands.

The Scientific Imaging businesses provide a range of imaging solutions, primarily for life sciences, academic research and customized OEM industrial imaging solutions. Princeton Instruments and Photometrics manufacture state-of-the-art cameras, spectrographs and optics for advanced research in physical sciences, life sciences research and spectroscopy imaging. Applications and markets include materials analysis, quantum technology and cell biology imaging using fluorescence and chemiluminescence. Lumenera primarily provides rugged USB-based customized cameras for markets such as traffic management, as well as life sciences applications.

“These Scientific Imaging businesses have similar capabilities and are highly complementary to Teledyne’s products and markets,” said Robert Mehrabian, Chairman and Chief Executive Officer of Teledyne. “Teledyne is a company committed to science and discovery. We are a key partner to high-technology businesses, government agencies and academic institutions across the globe. Princeton Instruments and Photometrics will provide Teledyne new products serving life sciences customers and markets, while Teledyne will offer Lumenera greater opportunities in the industrial domain.”

“Teledyne is an ideal home for our Scientific Imaging businesses, their customers and our employees,” said Neil Hunn, Roper’s President and Chief Executive Officer. “We are thankful for the contributions these businesses have made to Roper and we wish them continued success. The proceeds from this transaction will enhance our ability to deploy capital and continue to compound value for our shareholders.”

The transaction is anticipated to close in the first quarter of 2019, and is subject to customary closing conditions, including regulatory approval.

https://www.biospace.com/article/releases/teledyne-to-acquire-scientific-imaging-businesses-of-roper-technologies/

Lilly Forecasts 10 Drugs Will Spur Revenue Growth in 2019

Shares of Eli Lilly are up nearly 5 percent in premarket trading after the company announced its financial guidance for 2019 shows expected revenue of between $25.3 billion and $25.8 billion that will be driven by revenue from branded drugs such as Trulicity, Taltz, Verzenio and the newly-launched Emgality.

Over the past five years, Indianapolis-based Eli Illy has launched 10 new drugs and that performance is expected to continue through 2019. This morning, Lilly said pipeline progress is expected through the next calendar year, which will include expected regulatory action in the United States for its hypoglycemia and migraine treatments, as well as others.

During an “investment community meeting” this morning, Lilly’s chairman and chief executive officer David A. Ricks said the company is “executing well” against its priorities to “launch with excellence, replenish the pipeline, improve productivity and develop talent.” Ricks added that not only has Lilly launched those new drugs over the past half-decade, but during that same time period it has also bolstered its pipeline with new drug candidates and has also attracted “world-class scientific talent” to the company.

“Our actions over the past several years have positioned Lilly to deliver significant value to our key stakeholders. Most importantly, they have benefited patients, many of whose lives are better because of new Lilly medicines,” Ricks said in a statement.

Those 10 drugs that were launched over the past five years are expected to account for more than 45 percent of human pharmaceutical sales in 2019, Joshua Smiley, Lilly’s chief financial officer said. Smiley noted that those 10 drugs have launched in “some of the fastest growing categories” of drugs and have continued to “deliver growth through increased volume, not price.” That means, Smiley said, “more and more people around the world are benefitting from Lilly medicines.”

During the investment meeting, Rocks said the company is poised for continued growth. He said the company sees “incredible scientific opportunities” to address health issues that affect an aging society. Looking at the future, Ricks said the company will develop medicines to transform the care of patients battling serious illnesses.

Lilly Chief Scientific Officer Daniel Skovronsky highlighted some of the company’s recent advancements, including the reshaping of its drug discovery engine. Lilly has a goal of decreasing the time from target identification to clinical testing to about three years. Additionally, the company hopes to increase the use of “externally-derived innovation” to access novel targets and discovery tools, Skovronsky said. When it comes to late-stage clinical trials, Skovronsky noted that the company has seen a “steady improvement” in the success rate of Phase III molecules in its pipeline due to a “greater emphasis on target validation, patient population, molecule optimization, more robust Phase II data, and better Phase III design.” That strength of trial design as reduced the average time from first human dose in clinical testing to potential commercial launch, the company added.

“Lilly has created an industry-leading late-stage development organization and now we are focused on transforming our drug discovery engine,” Skovronsky said in a statement. “With an attractive clinical pipeline, two new molecules achieving regulatory submissions and three entering Phase III in 2018, we are continuing an impressive period of productivity for Lilly Research Labs, and are on pace to deliver on the company’s goal to launch 20 new medicines in 10 years.”

As part of its 2019 financial guidance, Lilly said it anticipates divesting its remaining interest in Elanco Animal Health within one year of Elanco’s initial public offering.

While revenue is expected to grow off the backs of the drugs mentioned earlier, Eli Lilly does anticipate lower revenue from its erectile dysfunction drug Cialis and other products that have lost patent exclusivity. Revenue growth is also expected to be partially offset by the negative impact of foreign exchange rates, as well as continued price pressures in the U.S. and some international markets, the company said.

https://www.biospace.com/article/eli-lilly-forecasts-10-drugs-will-spur-revenue-growth-in-2019/

DBV Technologies pulls peanut allergy treatment from FDA review

DBV Technologies is withdrawing its marketing application for a peanut allergy therapy following discussions with the Food and Drug Administration, the company said Wednesday.

Based on feedback from regulators, DBV concluded that its submission lacked “sufficient detail regarding data on manufacturing procedures and quality controls.” The company believes it can re-file with the FDA without having to conduct any additional clinical trials, although when that will happen was not made clear.

DBV shares were halted at $14.15 ahead of the announcement.

The company is developing a wearable patch, called Viaskin Peanut, that is intended to build tolerance to peanut protein in kids with severe peanut allergy.

Last year, in a trial on more than 300 children with peanut allergies, about 35 percent of patients responded to Viaskin, but the overall results didn’t beat placebo by enough to meet the study’s primary goal. DBV blamed the failure on a statistical issue and a better-than-expected response in placebo patients.

The FDA did not cite any issues with the Viaskin clinical trial data in its recent meetings with the company, it said.

DBV’s setback could be a boost to Aimmune Therapeutics, which is expected to file a competing peanut allergy treatment with the FDA before the end of the year.

https://www.statnews.com/2018/12/19/dbv-technologies-peanut-allergy-fda-review/