This week, Phispers ferrets out global pharma news to bring you the latest on a drug for bipolar disorder, news about two Indian drug makers being put on import alert for refusing an FDA inspection and how GSK’s supply snags in Italy are hurting Denmark Former hedge fund
manager who paid an FDA official for tipoffs found deadLast week, a hedge fund manager – Sanjay Valvani (44) – was indicted for allegedly paying a former US FDA official for inside information on product approvals. On June 20, he was reportedly found
dead. According to a news report, Valvani was found by his wife at
his Brooklyn, New York, home with a neck wound. A suicide note and a knife were
also recovered from his home.Valvani had worked at Visium Asset Management. During 2005 to 2011, he had allegedly paid a monthly sum to Gordon Johnston, who once worked as a deputy director of the FDA’s Office of Generic Drugs, for tips. Indian pharma majors
among 200 under scrutiny for quality of drugs sold For the first time in India, the Drug Controller General of
India (DCGI) has launched inspections against 200
drug makers, including pharmaceutical biggies like Cipla and Pfizer, for
allegedly selling poor quality medicines and for not complying with manufacturing
norms. An official of the DCGI told a newspaper that the regulator
has already inspected 36 drug manufacturing plants over the last three months. In the second phase, the DCGI will inspect 20 more
facilities. Notices have also been sent to Cipla and Pfizer informing them of
the impending inspection and the violations found in their products. Cipla
maintained it has not received any intimation so far, while Pfizer did not
comment. Phalanx Labs and
Cheryl Labs refuse FDA inspection, put on the Red List The US Food and Drug Administration (FDA) banned two Indian drug manufacturers – Cheryl
Laboratories and Phalanx
Labs – from shipping products to the US after both the firms refused to allow FDA teams to visit their manufacturing sites for an inspection. Both the firms were put on FDA’s import alert list, also known as the Red List. According to the FDA policy: “The refusal to permit inspection of a foreign facility or provide reasonable access to FDA’s
inspectional personnel, combined with other evidence, provides an appearance
that the firm’s products are manufactured, processed, or packed under insanitary conditions.” Cheryl Laboratories stopped FDA inspectors from visiting its
facility in Navi Mumbai, while Phalanx did not let inspectors visit their site
in Visakhapatnam. Cheryl makes creams, ointments, liquid pharmaceutical, antiseptic products and gels from its Navi Mumbai facility. Phalanx’s Vizag facility produces 15 active pharmaceutical ingredients (API) – including erectile dysfunction drugs, ulcer medications and anticoagulants – and chemical intermediaries. Eli Lilly loses
patent infringement case in ChinaLast week, China’s apex court rejected the appeal of US pharmaceutical company Eli Lilly
against Jiangsu-based Changzhou
Watson Pharmaceutical in a long-standing patent infringement case.Eli Lilly and Changzhou Watson have been involved in patent infringement disputes for over a decade over Changzhou Watson’s production of olanzapine,
an anti-psychotic drug. The court also overturned a previous ruling on patent infringement in favor of Eli Lilly, that had ordered Changzhou Watson to pay Eli Lilly millions in compensation. The investigators concluded that “the alleged infringement does not fall into the scope of patent protection in the case.”This is the first time that the apex court in China has
designated technical investigators in a lawsuit to help clarify the technical
details of the case. Using old compounds
to create new drug for bipolar disorderBack in 2010, a group at the University of Oxford was
looking for ways to treat
bipolar disorder by using lithium. Though the drug is known to work well in
bipolar disorder, it also has side effects. Therefore, the group – headed by a young physicians called Grant Churchill – asked a physician Justyn Thomas to screen all 450 compounds in the US National Institutes of Health (NIH) Clinical Collection, a library of drugs that had passed safety tests in humans but, for various reasons, had never reached the market. Thomas experimented with these compounds. What took birth was a drug called ebselen, which showed the same benefits as lithium. Churchill’s group did a small trial and found that ebselen could be used safely in healthy volunteers. The University of Oxford has now teamed up with a
pharmaceutical company to run clinical trials of ebselen for bipolar disorder. Former CEO of Warner
Chilcott acquitted in kickback caseLast week, the US federal court jury acquitted
W. Carl Reichel – a former Warner Chilcott executive – of paying bribes to doctors to lure them to boost prescriptions. The decision is being seen as a setback for the US
government which has initiated a new effort to hold high-ranking executives at
pharma and other companies accountable for such activities. Federal prosecutors charged Reichel with crafting a strategy
to give doctors money, free meals, and phony speaking fees in exchange for
writing prescriptions of Warner-Chilcott drugs between 2009 and 2012. He was also charged with providing sales representatives
with unlimited expense accounts in order to wine and dine with doctors. GSK’s supply snag in Italy creates drug shortage in DenmarkGlaxoSmithKline
had temporarily suspended manufacturing at its Parma
site in Italy that manufactures sterile products, to investigate
environmental monitoring.This has led to shortages of commonly used opioid anesthetic
in Denmark. The factory has now recommenced manufacturing. However, a small
number of countries have experienced shortages of certain products since April.
In Denmark, doctors said they were also running out of the anesthetic
Ultiva,
which is preferred by patients since they wake up quickly after surgery. The Parma factory also manufactures GSK’s new injectable drug Nucala
for severe asthma and Benlysta for lupus. However, these were reportedly not in
short supply. Zydus buys two ANDAs
from Teva; Cipla heads to RussiaIndia’s Zydus
Cadila has strengthened its US portfolio by acquiring two abbreviated new
drug applications (ANDAs) from Israel's Teva.
The divestiture by Teva is in line with a precondition to its acquisition of Allergan’s generic business. The ANDAs have been acquired by Zydus
Cadila’s 100 percent subsidiary Zydus Worldwide DMCC and the transaction will be financed through the group's internal accruals. The estimated market size of the two ANDAs is around US $ 200 million.Meanwhile, another Indian company – Cipla – has
entered into an
alliance with Russia’s National Immunobiological Company (Nacimbio) for
innovative antiviral medical products for HIV and hepatitis C treatment and
technology transfer and API manufacturing. As a part of this agreement,
Nacimbio, along with Cipla, will set up a manufacturing facility in Russia for
antiretroviral drugs.
Share