GSK's overhaul begins under new CEO; Sandoz loses US$ 940 million lawsuit

GSK’s overhaul begins under new CEO; Sandoz loses US$ 940 million lawsuit

This week, Phispers brings you news on GSK, whose new CEO is planning a slew of initiatives to make the British drug giant more competitive. This means more challenges for Luke Miels, AstraZeneca CEO Pascal Soriot’s former deputy who is joining GSK as head of pharma division. Soriot, on the other hand, put all rumors to rest in a memo to his staff. In other news, Donald Trump unveiled a glass vial project that will create more jobs in America. And Teva announced job cuts in Israel. While Momenta-Sandoz lost a case to Amphastar.

GSK overhaul begins under new CEO; AZ’s Soriot puts (Teva) rumors to rest in a memo

Pascal Soriot, chief executive of AstraZeneca, put all rumors to rest and told his staff that he expects to work together with them and see the company succeed. A report in the Israeli media earlier this month had said Soriot was in talks to join Teva. Last week, PharmaCompass reported that Soriot had dropped the offer.

Though he did not mention Teva, in a memo, Soriot said: “Together, we are poised to achieve something remarkable and that few thought possible…Nothing can break the momentum you have established, and certainly not rumors.”

Soriot is reportedly attending the European Society for Medical Oncology (ESMO) annual meeting in Madrid in September, in case AstraZeneca has its clinical data on its new immunotherapy medicine ready to present at the event.

Meanwhile, Soriot’s deputy, Luke Miels, is joining GlaxoSmithKline as head of its pharma division. And if news reports are to be believed, employees are going to need courage to work under the Emma Walmsley, the new CEO of the British drug giant.

Walmsley is looking for ways to make GSK more competitive. And in order to achieve that, she is pushing some functions and a lot of accountability into GSK’s three divisions. Their leaders will own the successes, as well as any failures.

According to news reports, GSK is selling its Horlicks brand in the UK, shutting the Slough plant where the malt drink is made and is abandoning a proposed US$ 457 million (£350 million) biopharmaceutical manufacturing plant in Cumbria.

Walmsley also wants to improve drug research productivity, and wants GSK to have fewer but potentially more lucrative new drug launches in the future. GSK is planning on scrapping more than 30 drug development programs and will focus 80 percent of its R&D budget on the top candidates in four therapeutic areas and potentially exit the rare disease space.

Momenta-Sandoz lose case to Amphastar; AbbVie to pay US$ 150m in damages

In the US, Amphastar Pharmaceuticals won a case in a federal court against Momenta Pharmaceuticals Inc and its partner Novartis AG’s Sandoz unit. The two had sought nearly US$ 940 million in damages against Amphastar.

Momenta and Sandoz had filed the lawsuit in 2011 after the US Food and Drug Administration (USFDA) had approved Amphastar’s generic version of Sanofi’s blockbuster Lovenox, an anticoagulant used to treat and prevent blood clots.

The two companies had accused Amphastar of infringing on a patent held by them, through the production of a generic version of the blood-thinner Lovenox.

In a statement, Momenta CEO Craig Wheeler said the company was disappointed and was considering its options, including a potential appeal. “We continue to believe in the importance of investing in innovative techniques for bringing products to market and protecting those innovations from unauthorized use,” he said.

Momenta and Sandoz suffered a major setback earlier this year when Pfizer’s fill/finish manufacturing facility in McPherson, Kansas, received a warning letter from the USFDA. The compliance concern had been initially revealed by Momenta in a press statement as the company, in collaboration with Sandoz, is developing a generic version of Teva’s long-acting Copaxone® 40mg/mL (glatiramer acetate injection). Sandoz had tied up with Pfizer as its fill/finish manufacturing partner.

Copaxone generated US$ 4.22 billion in sales last year.

Meanwhile, a federal jury in Chicago found AbbVie Inc fraudulently misrepresented the risks of its testosterone replacement drug — AndroGel. The jury ordered AbbVie to pay US$ 150 million in punitive damages.

A lawsuit had been filed in 2014 against AbbVie by Jesse Mitchell and his wife. The decision in the Mitchell case is the first in a series of test trials aimed at helping plaintiffs and manufacturers of AndroGel assess the range of damages and define a legal strategy and settlement options for such trials.

The jury said AbbVie was not “negligent or strictly liable” for a heart attack Mitchell suffered after taking AndroGel. However, it said AbbVie falsely marketed the drug. And, it did not award Mitchell compensatory damages for his injuries and losses.

Trump unveils glass vial project that is likely to create 4,000 jobs in the US

Last week, the US President Donald Trump announced an initiative to manufacture a new kind of glass for injectable drug vials. Corning Inc is making a US$ 500 million investment along with pharma giants Merck and Pfizer to manufacture these vials, which are likely to create nearly 1,000 jobs at facilities in New York and New Jersey and another ‘yet to be announced’ site in southeastern USA.

This initiative was part of Trump's ‘Made in America’ week, during which he showcased America-made products. Trump also defended his administration’s ‘America First’ policies. He was joined by the CEOs of Corning, Merck and Pfizer.

Trump said the deal could eventually result in a total investment of US$ 4 billion and create around 4,000 jobs. “This initiative will bring a key industry to our shores that for too long has been dominated by foreign countries. We’re moving more and more companies back into the United States,” Trump said.

According to Trump, the glass is called Valor Glass and is a “substantial improvement” in quality over existing products. It has superior strength and is more damage-resistant.

In Israel, Teva pulls out the job axe; Japan’s Mitsubishi Tanabe buys Neuroderm

Teva Pharmaceutical Industries recently announced that it is beginning negotiation with the labor groups in Israel. It is expected to cut 300 to 350 workers and managers at production sites in Histadrut and Ramat Hovav in the coming months.

This move will be yet another step towards Teva’s restructuring and business focus, aimed at bolstering the competitiveness of its sites in Israel.

Post this announcement, Histadrut called a work dispute, which will permit employees to strike in 14 days time. Teva currently has 7,000 employees in Israel.

Histradrut spokesman Yaniv Levy said: “We will not accept any unilateral measure in which workers are laid off at Teva. We expect the company’s management to act responsibly, and not to involve Teva’s plants in Israel in a series of conflicts that will escalate labor relations.”

Meanwhile, Japan's Mitsubishi Tanabe Pharma has agreed to buy Israeli drug maker Neuroderm for US$ 1.1 billion in cash as part of a strategy to grow its business in the US.

Mitsubishi Tanabe said it is particularly attracted by Neuroderm’s Parkinson’s disease drug that is in advanced clinical trials in the US and Europe and is likely to be launched in 2019.

A minor molecule twist could be the solution to cancer that killed Steve Jobs

Last week, a nuclear medicine targeted at the type of cancer that killed former Apple Inc co-founder and CEO Steve Jobs got a nod from the European Medicines Agency (EMA), boosting prospects for its developer — Advanced Accelerator Applications (AAA).

The EU drugs regulator said its Committee for Medicinal Products for Human Use (CHMP) had recommended the product — Lutathera (lutetium 177 dotatate). This emerging treatment targets gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. The drug is likely to get a full approval in the coming two months.

Stefano Buono, chief executive officer of AAA, said the company was also ready to re-file its application for US marketing approval with the USFDA this month.

This French biotech company has described the new drug as a “multi-hundred million” dollar opportunity. Lutathera has the potential to transform AAA’s fortunes.

Buono’s AAA, which was spun off from Europe’s physics research centre CERN 15 years ago, had sales from existing diagnostic products of US$ 34.9 million in the first quarter of 2017. Lutathera is unusual in harnessing the same molecule that is already used to diagnose cancer to also deliver treatment.

After Celgene, Cardinal Health pulls out of China due to regulatory concerns

After Celgene decided to reduce its footprint in China earlier this month, in order to support only its clinical development and regulatory affairs activities in the country, this week we heard about US drug distributor Cardinal Health putting its China business on the block.

As per news reports, state-backed Chinese pharma companies have evinced interest in a deal that may be worth up to US$ 1.5 billion. Shanghai Pharmaceutical, China Resources Pharmaceutical, and Sinopharm are among those evincing interest in buying Cardinal Health, one of China’s largest drug distributors.

Ohio-based Cardinal wants to exit the country due to concerns around China's upcoming drug distribution reform, which is likely to slow down its growth. Cardinal has also been diversifying — in April it announced a US$ 6.1 billion deal for Medtronic Plc’s medical supplies units. It has reportedly hired Lazard as an adviser for the China sale and the first round of bidding is due later this week.

Meanwhile, Celgene is offloading its Chinese operations to the biopharmaceutical major Beigene. It is also giving Beigene the rights to Abraxane, Revlimid and Vidaza in China. This way, Beigene will assume responsibility for making and selling the approved drugs, along with Celgene’s pipeline prospect CC-122 in China.

Celgene had also announced that it would buy a stake in BeiGene to help develop and commercialize the China-based cancer immunotherapy developer's treatment for solid tumor cancers, expanding its position in the field of immuno-oncology.

When the deal closes in the third quarter of this year, Beigene will instantly become a commercial-stage biotech.

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“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”

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