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Trump nominates new FDA head; import alert lifted for Sun’s Mohali facility

Trump nominates new FDA head; import alert lifted for Sun’s Mohali facility

This week, Phispers brings you news about President Trump’s choice for new FDA commissioner. There is news from India regarding lifting of the import alert on Sun Pharma, a new instance of data integrity violations and a legal setback for Bayer. Meanwhile, Novo, Pfizer and Merck adopt new means to grow their business. Read on.


President Trump nominates Scott Gottlieb as FDA’s new commissioner

Last week, the White House announced that President Donald Trump has nominated Scott Gottlieb as the new commissioner of the US Food and Drug Administration (FDA).

Gottlieb is a physician who has served as deputy commissioner for medical and scientific affairs with the FDA during the George W. Bush administration. He is currently a partner at New Enterprise Associates (NEA), a global venture capital firm specializing in healthcare investments. He is also a resident fellow at the American Enterprise Institute.

“Gottlieb is an advocate of faster, flexible approval of drugs especially where it comes to diseases of material unmet need,” Bernstein analyst Ronny Gal said in a report.

Among the topics that Dr. Gottleib has recently written are: “EpiPen shows a path to solve the bigger drug pricing challenge”; “How Congress can make drug pricing more rational”; and “How to boost competition in Obamacare

Gottleib comes with a strong history of corporate ties. In the last few years, Gottleib has taken more than US$ 400,000 from drugmakers, served on many corporate boards and forged several corporate ties while working for NEA.

In the past too, corporate ties have hogged headlines when FDA heads were being chosen. But this didn’t come in the way of the former President Barack Obama, who chose Robert Califf as the FDA commissioner. Califf left his position in January.

Among the companies from whom Gottlieb received consulting fees is GlaxoSmithKline (about US$ 60,000 in 2015 and US$ 100,000 in 2014). Gottlieb served as a member of GSK’s product investment board for several years.

FDA to lift import alert off Sun Pharma’s Mohali facility

The US FDA has informed Sun Pharmaceutical Industries that it will lift the import alert imposed on the latter’s Mohali manufacturing facility and remove the facility from the Official Action Initiated (OAI) status, Sun Pharma said in a press statement.

The Mohali facility came into Sun Pharma’s fold when it acquired Ranbaxy Laboratories in 2015. The US FDA had taken action against the Mohali facility in 2013 when it ordered the facility to be fully subject to Ranbaxy’s Consent Decree of Permanent Injunction. Certain conditions of the consent decree will continue to be applicable to the Mohali facility. 

This lifting of import alert will clear the path for Sun Pharma to supply approved products from the Mohali facility to the US market, subject to normal FDA regulatory requirements.

Data-integrity violations emerge out of India yet again

Badrivishal Chemicals & Pharmaceuticals, a manufacturer of Docusate Sodium, was placed on FDA’s import alert list in December 2016. FDA recently posted the warning letter issued to the site, highlighting various deviations from current good manufacturing practice (cGMP) for active pharmaceutical ingredients (API).

The facility used water as a drug component and for cleaning the facility and equipment. However, investigators found that while the company was aware about microbial contamination in the water for multiple months, they failed to investigate these deviations. The firm also failed to test the source water used in its water purification system. The water source is a river in the vicinity which passes through farmland, where it is subject to agricultural runoff and animal waste, before it reaches the Badrivishal manufacturing site.

FDA’s concern is that contaminated water has been the root cause of multistate outbreak of infections and multiple recalls by other drug manufacturers of non-sterile liquids, including instances of adulteration with Burkholderia cepacia, an opportunistic pathogen.

FDA investigators also found a large number of trash bags behind a building which contained torn original laboratory and production records, such as analytical test reports, water testing reports, and sample notebooks.

Also joining Badrivishal on the Import Alert list last week, were China-based companies — CR Zizhu Pharmaceutical and Qinhuangdao Zizhu Pharmaceutical. Qinhuangdao is a manufacture of hormone products like LevonogestrelTibolone and Ethinylestradiol.

Bayer suffers a major patent setback in India

In a major setback for German pharma giant Bayer in India, the Delhi High Court granted Alembic Pharmaceuticals and Natco Pharma the right to export the main ingredients of two of Bayer AG’s top-selling drugs used to manufacture generics in other countries.

The court’s decision allows continued exports of sorafenib, the API in Bayer’s cancer drug Nexavar, and rivaroxaban, used to make its blockbuster blood thinner Xarelto, for research purposes. Together, Nexavar and Xarelto garnered about US$ 4.2 billion in revenue last year for Bayer.

Bayer’s lawsuit was an attempt by the German drugmaker to halt exports of the APIs needed to make test batches of its patented products. Natco said in court papers it was seeking to sell sorafenib to a Chinese company, while Alembic said its rivaroxaban was destined for Brazil and the Middle East. 

Both said the exports were for the purpose of conducting clinical trials and research — not for any immediate commercial purpose. 

Natco has been barred from exporting sorafenib by a court injunction since Bayer first filed the lawsuit in 2014.

FDA and EMA accept Merck, Pfizer’s applications for diabetes drugs

Merck and Pfizer maybe late entrants in the field of SGLT2 inhibitors, but they are still trying be part of the SGLT2 jamboree.

SGLT2 inhibitors are an FDA-approved class of prescription medicines used with diet and exercise to lower blood sugar in adults with type 2 diabetes.

In a bid to catch up with Eli Lilly and Boehringer Ingelheim's Jardiance (empagliflozin), Johnson & Johnson's Invokana (canagliflozin) and AstraZeneca's Farxiga (dapagliflozin), Merck and Pfizer announced that the FDA and European Medicine Agency (EMA) had accepted applications not just for their SGLT2 diabetes competitor ertugliflozin, but for two combinations as well.

The combinations submitted are those of ertugliflozin and Januvia® (sitagliptin), and for ertugliflozin and metformin.

Novo’s new CEO looks for growth through acquisitions

While Pfizer and Merck are looking at getting an approval for their diabetes drugs, Novo Nordisk's new chief executive is looking at making acquisitions to broaden the Danish drugmaker's product line-up. Novo is the world’s biggest diabetes company.

In an interview with Reuters, Lars Fruergaard Jorgensen, who took charge as Novo’s CEO in January this year, said: “Across our business we need to increasingly look for external innovation.” 

"In my view we should do smaller deals; low single-digit billions of dollars,” he added.

Novo had recently approached Global Blood Therapeutics, a US biotechnology company focused on serious blood disorders, valued at close to US$ 1.5 billion, to discuss a potential takeover, a Reuters report said.

Novo, which is known for its sector-beating growth, had announced last month that its sales and profits might actually slip in 2017.


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