Big Changes at Teva - FDA Approves One of the World's Costliest Drugs

Big changes at Teva; FDA approves one of the world’s costliest drugs

This week, Phispers brings you news about hefty pay packages at AstraZeneca and Mylan; FDA’s Form 483 observations at three of India’s leading pharma companies and news about changes at a debt-ridden Teva. Plus, there is news on Japanese drug makers Takeda and Otsuka. Read on.

Shareholders protest against AstraZeneca CEO’s pay package

Last week, AstraZeneca suffered a setback from its shareholders in the form of protest over the US$ 17.3 million (£13.4 million) package for its chief executive — Pascal Soriot. In what seemed to be a repeat of a similar episode three years back, nearly 40 percent of investors voted against the pharmaceutical group’s 2016 remuneration report at its annual meet in London. This is about the same percentage of investors who raised objections to remuneration numbers in 2014. Back then, the package in question was to the tune of US$ 4.31 million (£3.34 million), plus potential performance awards of US$ 5.62 million (£4.35 million).

Soriot’s US$ 17.3 million package included a long-term incentive plan and other rewards.

However, the 39 percent vote against AstraZeneca’s 2016 compensation report has no direct consequences. It’s only an advisory.

Mylan chairman’s $97.6 million pay package: Similarly, Mylan chairman’s pay package made headlines this week, after much furor last year over the skyrocketing price of Mylan’s life-saving EpiPens. Mylan chairman, Robert Coury, received a compensation of US$ 97.6 million in 2016. And that doesn’t include an additional US$ 66.3 million in other retirement benefits and payments that Coury received last year as part of a transition from executive chairman to a ‘non-employee chairman role’. Coury will also continue to receive a US$ 1.8 million per year ‘cash retainer’ by virtue of a deal made with Mylan last year.

Big changes at Teva: Cancer drug portfolio being put on the market

Rumors about big changes at Teva have been around for quite sometime. But recently, an earlier report about longtime CFO Eyal Desheh being eased out got confirmed.

Following the report about Desheh, there was another Bloomberg report that said the company’s specialty cancer drug portfolio is being put on the market.

Attributing to sources, the report said Teva is speaking with financial advisers about the possible sale of the oncology business, which includes treatments for leukemia and a slow-growing form of lymphoma.

Teva acquired the generics business from Allergan for US$ 40.5 billion last year. This left the company with a heavy debt and underperforming divisions.

And after the exit of CEO Erez Vigodman more than two months ago, the rumor mills are abuzz with talk of “thousands of job cuts”. There have been reports that 6,000 jobs are being cut, but the company has denied them.

GSK’s new CEO wants bigger launches

British drug major GlaxoSmithKline's new chief executive — Emma Walmsley (47) — aims to improve returns in drug development, and wants fewer but bigger new medicine launches in the future.

According to a Reuters report, Walmsley said recently that her priority was the pharmaceuticals unit, where she wants commercial considerations to be given greater weight in early investment decisions.

Speaking post the announcement of first-quarter results, Walmsley said: “We’d like to have probably fewer and more focused priorities, to have bigger launches.” According to her, this would involve tough choices and the closure of some research programs.

Novo to settle probe related to marketing of diabetes drugs

Novo Nordisk has agreed to settle a probe in the US into the marketing of its diabetes drugs. According to a whistle-blower lawsuit, Novo allegedly disguised salespeople as medical educators and paid kickbacks to persuade doctors to prescribe its medicines, including its diabetes drug Victoza that is covered by federal health-insurance programs.

These allegations were disclosed when the lawsuit was unsealed by a judge. The investigation dates back to 2011. According to Novo’s 2016 annual report, the investigation focuses on claims of illegal marketing of Novo’s top-selling Victoza diabetes drug and other products.

“We’ve reached an agreement in principle to settle certain claims related to this investigation,” Ken Inchausti, a US-based spokesman for Novo, said.

FDA okays BioMarin’s Brineura; Bayer’s Stivarga approved for liver cancer

Last week, the US Food and Drug Administration (FDA) gave nod to BioMarin Pharmaceutical Inc’s drug — Brineura. It is a treatment for a rare genetic disorder — a form of Batten disease — that ravages the nervous system and can cause symptoms ranging from seizures to trouble coordinating muscles to vision loss. The disease can affect both adults and children.

The list price of BioMarin’s Brineura is a whopping US $ 702,000. This makes this the second most-expensive drug after Horizon Pharma’s Ravicti (priced at US $ 793,632).

Bayer’s Stivarga gets nod for liver cancer: The FDA also expanded the approved use of Stivarga (regorafenib) to include treatment of patients with hepatocellular carcinoma (liver cancer), who were previously being treated with the drug sorafenib. This is the first FDA-approved treatment for a liver cancer since the approval of sorafenib in 2007.

Produced by Bayer, Stivarga is a kinase inhibitor that works by blocking several enzymes that promote growth of cancer. The drug is already approved for treatment of colorectal cancer and gastrointestinal stromal tumors that are no longer responding to previous treatments.

What’s in a name? Billions of dollars in tech costs for biosimilars

A new US FDA guidance on how biological products licensed under the Public Health Service Act (PHS Act) need to be named is playing havoc with a number of healthcare organizations.

According to this naming convention, the nonproprietary name designated for “each originator biological product, related biological product, and biosimilar product will be a proper name that is a combination of the core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters.”

According to the healthcare organizations, this step will cost the health care system billions of dollars in technology costs.

According to a healthcare data provider — Wolters Kluwer Health — healthcare organizations (such as hospitals, insurers, and physician practices, as well as government agencies) will “collectively, spend billions of dollars to redesign and reprogram information technology systems to accommodate this new mandate.” The organization mentioned this in a letter to the White House Office of Management Budget.

Decision on relocation of EMA from London likely in October

The European Union will be taking a decision in October this year on where to relocate the European Medicines Agency (EMA), currently based in London, after Brexit.

According to the Romanian President, Klaus Iohannis, EU leaders met in Brussels last week and talked about the relocation issue “for five minutes”.

The European Council President Donald Tusk proposed that EU leaders should agree in June on the criteria to be used for the relocation of the EMA. The final decision should be taken in fall, Iohannis said.

Takeda’s US $5.2 billion buy begins to pay off; Will Otsuka be next?

Takeda’s US$ 5.2 billion gamble in the form of a buyout of Ariad paid off recently when the US FDA approved the late-stage cancer drug brigatinib, that Takeda acquired via this buyout. The FDA has approved brigatinib for ALK-positive cases of non-small cell lung cancer.

Takeda had acquired Ariad in January this year. Takeda can now realize its projections of over US$ 1 billion in annual sales from brigatinib — which will be marketed as Alunbrig. Analysts, however, have predicted US$ 500 million to US$ 800 million in sales for brigatinib.

It seems Japanese drugmaker Otsuka Pharmaceutical maybe next in line for receiving pay-offs from its investments. Last year, Ostuka had spent over a billion dollars to partner with Akebia on its experimental anemia drug — Vadadustat — in the US market. But the pact was only a starting point. Last week, Otsuka came back to grab Europe, China, Russia and much of the rest of the world, by paying another US$ 208 million in committed capital.

There is more action at Otsuka. India accounts for about 25 percent of the world’s tuberculosis cases. And Otsuka plans to apply for approval of its TB drug — delamanid — in India within three months, a senior company official said.

FDA Form 483 observations for India’s Aurobindo, Lupin and DRL

Aurobindo Pharma: The US FDA recently handed an inspection report (Form 483) with six observations to major generic drugmaker Aurobindo Pharma.The inspection at Aurobindo Pharma’s Hyderabad facility was held during April 10 to 18 this year.

The six observations relate to the company's laboratory system, including a repeat observation from an inspection the year before.

The company’s “laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures,” the FDA said. And similar to observations we have seen in other recent inspections, FDA investigators found that Aurobindo’s quality control unit did not adequately investigate out-of-specification (OOS) test results.

Lupin: Similarly, Lupin’s Goa facility also received a form 483 from the US FDA, that cited three observations related to violation of good manufacturing practices (GMPs) following an inspection of the site between March 27 and April 7, 2017.

The FDA observed that Lupin failed to review and investigate unexplained discrepancy and OOS components of a product batch at the facility.

“From January 2016 to March 2017, your firm has invalidated several initial out of specification (product) results…You invalidated the initial results without adequate investigation, performed re-testing using new samples and reported the average results of replicate re-tests,” the FDA said in the Form 483.

Similar problems have been cited in past inspections at the Goa facility.

Dr. Reddy’s: Last week, drug major Dr Reddy's Laboratories (DRL) said the US FDA has issued it a Form 483 with 11 observations after inspecting its manufacturing plant in Hyderabad.

“The observations by the US FDA are mostly procedural in nature, reflecting the need to improve people capabilities and strengthen documentation and laboratory systems,” Dr Reddy’s said in a statement.

The audit of the plant was completed last week and the company said it will address the observations comprehensively and respond to the regulator within the stipulated time.

Zero observations for Strides Shasun: Strides Shasun announced that its API manufacturing facility at Cuddalore (in Tamil Nadu, India) was recently inspected by US FDA. The company has successfully completed the US FDA inspection without any Form 483 observations.

The PharmaCompass Newsletter – Sign Up, Stay Ahead

Feedback, help us to improve. Click here

Image Credit : Expensive! by Ged Carroll is licensed under CC BY 2.0

“ 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.”